Diphen

Benzocaine, Benzalkonium Chloride, Lidocaine Hydrochloride, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, And Bismuth Subsalicylate


Remedy Pack Llc
Human Otc Drug
NDC 82652-021
Diphen also known as Benzocaine, Benzalkonium Chloride, Lidocaine Hydrochloride, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, And Bismuth Subsalicylate is a human otc drug labeled by 'Remedy Pack Llc'. National Drug Code (NDC) number for Diphen is 82652-021. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Diphen drug includes . The currest status of Diphen drug is Active.

Drug Information:

Drug NDC: 82652-021
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Diphen
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Benzocaine, Benzalkonium Chloride, Lidocaine Hydrochloride, Hydrocortisone, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Calcium Carbonate, Ibuprofen, Loratadine, Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, Potassium Chloride, Magnesium Oxide, Meclizine Hydrochloride, And Bismuth Subsalicylate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Remedy Pack Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Kit
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 10 May, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 09 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA076134
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Remedy Pack LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:198440
204602
308761
310965
311372
313884
995666
1012100
1043690
1049630
1367204
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
82652-021-011 KIT in 1 CARTON (82652-021-01) * 1 TABLET, FILM COATED in 1 PACKET (82652-022-01) * 2 TABLET, FILM COATED in 1 PACKET (82652-025-01) * 2 TABLET in 1 PACKET (82652-030-01) * 2 TABLET in 1 PACKET * 1 TABLET, FILM COATED in 1 PACKET (82652-031-01) * 2 TABLET in 1 PACKET (82652-032-01) * 2 TABLET, CHEWABLE in 1 PACKET (82652-026-01) * 2 TABLET, FILM COATED in 1 PACKET (82652-024-01) * 2 TABLET, CHEWABLE in 1 PACKET (82652-023-01) * .5 g in 1 PACKET (82652-028-01) * .9 g in 1 PACKET (82652-027-01) * .9 g in 1 PACKET (82652-029-01) * .75 g in 1 PACKET (82652-033-01)10 May, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose topical antiseptic, topicall analgesic

Purposes first aid antibiotics

Purpose anti-itch

Purpose oral anesthetic

Purpose antacid

Active ingredient (in each tablet): acetaminophen 325mg purpose: pain reliever/ fever reducer active ingredient (in each tablet): dextromethorphan hydrobromide 15mg purpose: cough suppressant active ingredient (in each tablet): guaifenesin 200mg purpose: expectorant active ingredient (in each tablet): phenylephrine hcl 5mg purpose: nasal decongestant

Purpose antiemetic

Purpose pain reliever/fever reducer

Purpose antihistamine

Purpose antihistamine

Purpose pain reliever/fever reducer

Purpose antihistamine

Purpose upset stomach reliever/antidiarrheal

Product Elements:

Diphen benzocaine, benzalkonium chloride, lidocaine hydrochloride, hydrocortisone, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, calcium carbonate, ibuprofen, loratadine, acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride, potassium chloride, magnesium oxide, meclizine hydrochloride, and bismuth subsalicylate pain relief benzocaine benzocaine benzocaine polyethylene glycol 400 polyethylene glycol 3350 peppermint oil saccharin sodium sorbic acid burn benzalkonium chloride and lidocaine hydrochloride benzalkonium chloride benzalkonium lidocaine hydrochloride lidocaine lidocaine hydrochloride anhydrous alcohol methylparaben mineral oil paraffin propylparaben water white petrolatum white wax hydrocortisone hydrocortisone hydrocortisone acetate hydrocortisone alcohol methylparaben mineral oil paraffin petrolatum propylparaben water white wax triple antibiotic bacitracin zinc, neomycin sulfate, and polymyxin b sulfate bacitracin zinc bacitracin neomycin sulfate neomycin polymyxin b sulfate polymyxin b polyethylene glycol 3350 polyethylene glycol 400 saccharin sodium fd&c blue no. 1 fd&c green no. 3 d&c green no. 5 fd&c red no. 3 d&c red no. 28 fd&c red no. 40 fd&c yellow no. 5 fd&c yellow no. 6 alcalak calcium carbonate calcium carbonate calcium cation carbonate ion aspartame croscarmellose sodium acacia magnesium stearate maltodextrin mineral oil sorbitol sucrose az;036 i-prin ibuprofen ibuprofen ibuprofen carnauba wax starch, corn hypromellose, unspecified ferric oxide red lactose, unspecified form magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone k30 silicon dioxide sodium starch glycolate type a stearic acid talc titanium dioxide 44;291 loradamed loratadine loratadine loratadine starch, corn lactose monohydrate magnesium stearate rx;526 cold relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine maltodextrin microcrystalline cellulose povidone, unspecified sodium starch glycolate type a stearic acid fr;12 diphen diphenhydramine hydrochloride diphenhydramine hydrochloride diphenhydramine carnauba wax silicon dioxide croscarmellose sodium d&c red no. 27 anhydrous dibasic calcium phosphate hypromellose, unspecified lactose, unspecified form magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified titanium dioxide 048;d medi-lyte calcium carbonate, potassium chloride, and magnesium oxide calcium carbonate calcium cation carbonate ion potassium chloride potassium cation chloride ion magnesium oxide magnesium cation microcrystalline cellulose silicon dioxide stearic acid magnesium stearate medi-meclizine meclizine hydrochloride meclizine hydrochloride meclizine anhydrous lactose silicon dioxide starch, corn d&c yellow no. 10 magnesium stearate microcrystalline cellulose sodium starch glycolate type a 44;403 extra strength apap acetaminophen acetaminophen acetaminophen starch, corn hypromellose, unspecified maltodextrin microcrystalline cellulose polyethylene glycol, unspecified sodium starch glycolate type a stearic acid titanium dioxide fr;33 diotame bismuth subsalicylate bismuth subsalicylate salicylic acid bismuth cation acacia aspartame calcium carbonate d&c red no. 27 dextrates magnesium stearate maltodextrin microcrystalline cellulose silicon dioxide rh;046

Indications and Usage:

Uses first aid to help prevent infection in minor cuts, scrapes and burns. for the temporary relief of pain and itching associated with: sunburn insect bites cuts minor skin irritations scrapes minor burns

Uses first aid to help prevent infection in: minor cuts scrapes burns

Uses eczema insect bites poison ivy poison oak poison sumac cosmetics jewelry soaps detergents seborrheic dermatitis psoriasas other uses of this product should only be under the advice and supervision of a doctor.

Uses for oral mucosal use only, as directed by dentist. for the temporary relief of pain due to minor dental procedures.

Uses for the relief of the following symptoms associated with acid indigestion sour stomach heartburn upset stomach

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies cough sore throat minor aches and pains headache nasal congestion helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever.

Uses for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness. for the reduction of fever.

Uses temporarily relieves minor aches and pains associated with headache toothache backache menstrual cramps common cold muscular aches minor arthritis pain temporarily reduces fever.

Uses active ingredients diphenhydramine hcl 25mg purpose antihistamine inactive ingredients may contain carnauba wax , colloidal silicon dioxide, croscarmellose sodium, d&c red #27, dicalcium phosphate , hypromellose, lactose , magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate , titanium dioxide

Uses for the temporary relief of minor aches and pains associated with headache muscular aches minor arthritis pain common cold toothache menstrual cramps for the reduction of fever.

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat

Uses nutritional support for the following symptoms due to excessive loss of perspiration heat fatigue muscle cramps heat exhaustion heat stroke replaces lost electrolytes helps provide rapid rehydration *this statement has not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure, or prevent any disease.

Uses temporarily relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including - heartburn - indigestion - nausea - gas - belching - fullness

Warnings:

Warning for external use only. do not use in the eyes over large areas of the body or on deep puncture wounds, animal bites, or serious burns in large quantities, particularly over raw surfaces or blistered areas stop use and ask doctor if the condition gets worse condition clears up and recurs within a few days condition persists for more than 7 days if pregnant or breast feeding, ask a health care professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warning for external use only do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.

Warning for external use only avoid contact with the eyes if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor do not use for the treatment of diaper rash. keep out of reach of children. if swallowed, get medical help or consult a poison control center right away.

Methemoglobinemia warning use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics. do not use for more than 7 days unless directed by a physician. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age when using this product avoid contact with eyes. if it occurs, flush with water. do n
ot exceed recommended dosage. if more than used for pain is accidently swallowed, get medical help or contact a poison control center right away. if pregnant or breast feeding,ask a health care professional before use. keep out of reach of children.

Warning do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period. ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescription drugs. stop use and ask a doctor if symptoms last more than 2 weeks if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Warning liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of the ingredients. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist be
fore taking this product. ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if new symptoms occur redness or swelling is present pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days you get nervous, dizzy or sleepless cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warning do not use for children under 12 years of age unless directed by a doctor for frequent or prolonged use except under the advice of a doctor ask a doctor before use if you have breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are taking sedatives or tranquilizers when using this product drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery do not exceed recommended dosage. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning allergy alert ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: hives skin reddening facial swelling rash asthma (wheezing) blisters shock if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed heart attack or stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed. do not use if you have ever had a
n allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug when using this product take with food or milk if stomach upset occurs stop use and ask a doctor if you experience any of the following signs of stomach bleeding: - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better you have symptoms of heart problems or stroke - chest pain - trouble breathing - weakness in one part or side of body - slurred speech - leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning do not use to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, contact a physician or poison control center immediately.

Warning liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse
redness or swelling is present if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warning do not use if you have ever had an allergic reaction to this product or any of its ingredients. ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. when using this product do not take more than directed. taking more than directed may cause drowsiness. stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.

Warning if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning reye's syndrome children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome a rare but serious illness. allergy alert contains salicylate. do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products do not use if you have bloody or black stool an ulcer a bleeding problem ask a doctor before use if you have fever mucus in the stool ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days when using this product a temporary and harmless darkening of the tongue and/or stool may occur. stool darkening should not be confused with melena. if
pregnant or breast-feeding, ask a health professional before use. keep this and all drugs out of reach of children. in case of accidental overdose, contact a physician or poison control center immediately.

Do Not Use:

Warning for external use only. do not use in the eyes over large areas of the body or on deep puncture wounds, animal bites, or serious burns in large quantities, particularly over raw surfaces or blistered areas stop use and ask doctor if the condition gets worse condition clears up and recurs within a few days condition persists for more than 7 days if pregnant or breast feeding, ask a health care professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Warning for external use only do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops keep out of reach of children. if swallowed, get medical help or contact a poison control center immediately.

Warning for external use only avoid contact with the eyes if condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor do not use for the treatment of diaper rash. keep out of reach of children. if swallowed, get medical help or consult a poison control center right away.

Methemoglobinemia warning use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. this can occur even if you have used this product before. stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy allergy alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics. do not use for more than 7 days unless directed by a physician. if sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly. for teething in children under 2 years of age when using this product avoid contact with eyes. if it occurs, flush with water. do not exceed recommended dosage. if more than used for pain is accidently swallowed, get medical help or contact a poison control center right away. if pregnant or breast feeding,ask a health care professional before use. keep out of reach of children.

Warning do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician, or take more than 19 tablets in a 24 hour period. ask a doctor or pharmacist before use if you are presently taking a prescription drug. antacids may interact with certain prescription drugs. stop use and ask a doctor if symptoms last more than 2 weeks if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Warning liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of the ingredients. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if new symptoms occur redness or swelling is present pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days you get nervous, dizzy or sleepless cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warning do not use for children under 12 years of age unless directed by a doctor for frequent or prolonged use except under the advice of a doctor ask a doctor before use if you have breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are taking sedatives or tranquilizers when using this product drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery do not exceed recommended dosage. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning allergy alert ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: hives skin reddening facial swelling rash asthma (wheezing) blisters shock if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed heart attack or stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed. do not use if you have ever had an allergic reaction to any other pain reliever/ fever reducer right before or after heart surgery ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic ask a doctor or pharmacist before use if you are taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin under a doctor's care for any serious condition taking any other drug when using this product take with food or milk if stomach upset occurs stop use and ask a doctor if you experience any of the following signs of stomach bleeding: - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better you have symptoms of heart problems or stroke - chest pain - trouble breathing - weakness in one part or side of body - slurred speech - leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning do not use to make a child sleepy with any other product containing diphenhydramine, even one that is used on skin ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers when using this product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, contact a physician or poison control center immediately.

Warning liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor ask a doctor before use if you have liver disease ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warning do not use if you have ever had an allergic reaction to this product or any of its ingredients. ask a doctor before use if you have liver or kidney disease. your doctor should determine if you need a different dose. when using this product do not take more than directed. taking more than directed may cause drowsiness. stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.

Warning if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Warning reye's syndrome children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome a rare but serious illness. allergy alert contains salicylate. do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products do not use if you have bloody or black stool an ulcer a bleeding problem ask a doctor before use if you have fever mucus in the stool ask a doctor or pharmacist if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days when using this product a temporary and harmless darkening of the tongue and/or stool may occur. stool darkening should not be confused with melena. if pregnant or breast-feeding, ask a health professional before use. keep this and all drugs out of reach of children. in case of accidental overdose, contact a physician or poison control center immediately.

When Using:

When using this product avoid contact with eyes. if it occurs, flush with water.

When using this product do not use more than directed

When using this product drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery do not exceed recommended dosage.

When using this product take with food or milk if stomach upset occurs

When using this product marked drowsiness may occur avoid alcohol beverages alcohol, sedatives and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children

When using this product do not take more than directed. taking more than directed may cause drowsiness.

When using this product a temporary and harmless darkening of the tongue and/or stool may occur. stool darkening should not be confused with melena.

Dosage and Administration:

Directions adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage children under 12 years: consult a doctor children under 2 years: consult a doctor

Directions clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage

Directions adult and children (2 years and over): apply to affected not more than 3 to 4 times daily children under 2 years: consult a doctor.

Directions apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use

Directions do not use more than directed adults and children: (12 years and older) chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. do not exceed 19 tablets in 24 hours. children under 12 years: do not give to children under 12 years of age.

Directions adults and children: (12 years and older) take 2 tablets with water every 6- 8 hours as needed. do not take more than 8 tablets in 24 hours. children under 12 years: do not give to children under 12 years of age.

Directions do not use more than directed to prevent motion sickness, take the first dose one hour before starting activity adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. do not exceed 2 tablets in 24 hours. children under 12 years: do not give to children under 12 years of age.

Directions do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see warnings ) adults and children: (12 years and older) take 1 tablet every 4 to 6 hours while symptoms persist. if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor. children under 12 years: do not give to children under 12 years of age.

Directions do not use more than directed adults and children: (12 years and older) take 1 to 2 caplets every 4 to 6 hours as needed. do not take more than 12 caplets in 24 hours, or as directed by a doctor. children under 12 years: do not give to children under 12 years of age.

Directions do not use more than directed adults and children: (12 years and older) take 2 tablets every 4 to 6 hours as needed. do not take more than 8 tablets in 24 hours. children under 12 years: do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Directions adults and children: (12 years and older) take 1 tablet daily; not more than 1 tablet in 24 hours. children under 12 years: do not give to children under 12 years of age. consumers with liver or kidney disease: ask a doctor before using.

Directions adults and children: (12 years and older) take 2 tablets as needed with a full glass of water may be repeated every hour as needed do not exceed 20 tablets in 24 hours children under 12 years: do not give to children under 12 years of age

Directions do not use more than directed chew or crush tablets completely before swallowing do not swallow tablets whole use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea do not exceed 16 tablets in 24 hours adults and children: (12 years and older) chew 2 tablets every 1/2 to 1 hour or 4 tablets every hour as needed. children under 12 years: do not give to children under 12 years of age.

Stop Use:

Stop use and ask doctor if the condition gets worse condition clears up and recurs within a few days condition persists for more than 7 days

Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops

Stop use and ask a doctor if symptoms last more than 2 weeks

Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or nasal congestion gets worse or lasts for more than 7 days fever gets worse or lasts for more than 3 days you get nervous, dizzy or sleepless cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: - feel faint - vomit blood - have bloody or black stools - have stomach pain that does not get better you have symptoms of heart problems or stroke - chest pain - trouble breathing - weakness in one part or side of body - slurred speech - leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new or unexpected symptoms occur

Stop using and ask a doctor if symptoms do not improve new symptoms occur pain or fever persists or gets worse redness or swelling is present

Stop use and ask a doctor if an allergic reaction to this product occurs. seek medical help right away.

Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

Package Label Principal Display Panel:

Principal display panel - kit carton remedy pack drug facts www.theremedypack.com principal display panel - kit carton


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.