Excedrin Pm Triple Action Caplets And Excedrin Tension Headache
Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8147Excedrin Pm Triple Action Caplets And Excedrin Tension Headache also known as Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Excedrin Pm Triple Action Caplets And Excedrin Tension Headache is 0067-8147. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Excedrin Pm Triple Action Caplets And Excedrin Tension Headache drug includes . The currest status of Excedrin Pm Triple Action Caplets And Excedrin Tension Headache drug is Active.
Drug Information:
| Drug NDC: | 0067-8147 |
| 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: | Excedrin Pm Triple Action Caplets And Excedrin Tension Headache |
| 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: | Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) 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: | OTC MONOGRAPH NOT FINAL |
| 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: | 01 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 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: | part343 |
| 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307686
404172
1593110
1593116
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0067-8147-01 | 1 KIT in 1 PACKAGE, COMBINATION (0067-8147-01) * 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE | 01 Jun, 2017 | N/A | No |
| 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:
Purposes pain reliever pain reliever nighttime sleep-aid
Purpose s pain reliever pain reliever aid
Product Elements:
Excedrin pm triple action caplets and excedrin tension headache acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate excedrin pm triple action caplets acetaminophen, aspirin (nsaid) and diphenhydramine citrate acetaminophen acetaminophen aspirin aspirin diphenhydramine citrate diphenhydramine benzoic acid calcium carbonate fd&c blue no. 1 low-substituted hydroxypropyl cellulose, unspecified hypromellose, unspecified magnesium stearate maltodextrin medium-chain triglycerides polydextrose polysorbate 80 povidone, unspecified starch, corn microcrystalline cellulose stearic acid talc titanium dioxide ferric oxide yellow zinc stearate light blue expm excedrin tension headache acetaminophen, caffeine acetaminophen acetaminophen caffeine caffeine benzoic acid d&c red no. 27 aluminum lake fd&c blue no. 2 fd&c yellow no. 6 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified starch, corn stearic acid titanium dioxide talc (caplet) eth
Indications and Usage:
Uses ⢠for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Uses ⢠temporarily relieves minor aches and pain due to: ⢠headache muscular aches
Warnings:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. 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. allergy alert: aspirin may cause a severe allergic reaction which may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 2 caplets 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 stomach bleed
Read more...ing 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 do not use ⢠if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin ⢠in children under 12 years of age ask a doctor before use if ⢠you have liver disease ⢠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, or kidney disease ⢠you are taking a diuretic ⢠you have asthma ⢠you have glaucoma ⢠you have a breathing problem such as emphysema or chronic bronchitis ⢠you have trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking ⢠a prescription drug for: ⢠diabetes ⢠gout ⢠arthritis ⢠any other drug, or are under a doctorâs care for any serious condition ⢠any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠do not drive a motor vehicle or operate machinery stop use and ask a doctor if ⢠an allergic reaction occurs. seek medical help right away. ⢠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 ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or last for more than 10 days ⢠painful area is red or swollen ⢠ringing in the ears or a loss of hearing occurs ⢠any new symptoms occur these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use aspirin during the last three months of pregnancy unless definitely 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. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings 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. liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 caplets 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 caffeine warning: the recommended dose of this product contains about as much caffeine as a cup of coffee. limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat do not use ⢠if you are allergic to acetaminophen ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains
Read more... acetaminophen, ask a doctor or pharmacist. 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 use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days 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. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. 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. allergy alert: aspirin may cause a severe allergic reaction which may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 2 caplets 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 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 do not use ⢠if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ⢠with any other product containing diphenhydramine, even one used on skin ⢠in children under 12 years of age ask a doctor before use if ⢠you have liver disease ⢠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, or kidney disease ⢠you are taking a diuretic ⢠you have asthma ⢠you have glaucoma ⢠you have a breathing problem such as emphysema or chronic bronchitis ⢠you have trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking ⢠a prescription drug for: ⢠diabetes ⢠gout ⢠arthritis ⢠any other drug, or are under a doctorâs care for any serious condition ⢠any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer ⢠sedatives or tranquilizers when using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠do not drive a motor vehicle or operate machinery stop use and ask a doctor if ⢠an allergic reaction occurs. seek medical help right away. ⢠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 ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or last for more than 10 days ⢠painful area is red or swollen ⢠ringing in the ears or a loss of hearing occurs ⢠any new symptoms occur these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use aspirin during the last three months of pregnancy unless definitely 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. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings 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. liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 caplets 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 caffeine warning: the recommended dose of this product contains about as much caffeine as a cup of coffee. limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat do not use ⢠if you are allergic to acetaminophen ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days 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. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠do not drive a motor vehicle or operate machinery
Dosage and Administration:
Directions ⢠do not use more than directed ⢠do not use in children under 12 years of age ⢠adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water ⢠do not take more than 2 caplets in 24 hours, unless directed by a doctor
Directions ⢠do not use more than directed ⢠adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠an allergic reaction occurs. seek medical help right away. ⢠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 ⢠sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. ⢠pain gets worse or last for more than 10 days ⢠painful area is red or swollen ⢠ringing in the ears or a loss of hearing occurs ⢠any new symptoms occur these could be signs of a serious condition
Stop use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel (excedrin pm headache) do not take both products at the same time. use products as directed. ndc 0067-2056-24 excedrin ® pm headache acetaminophen, aspirin (nsaid) and diphenhydramine citrate pain reliever/nighttime sleep-aid triple action formula caffeine-free non-habit forming 24 caplets tamper-evident bottle do not use if inner foil seal imprinted with âsealed for your protectionâ is broken or missing distributed by: gsk consumer healthcare warren, nj 07059 ©2015 gsk or its licensor. visit us at www.excedrin.com 46172695 excedrin pm 24 count carton
Principal display panel (excedrin tension headache) ndc 0067-8139-02 excedrin ® tension headache acetaminophen and caffeine pain reliever / pain reliever aid aspirin free 100 caplets tamper-evident bottle do not use if inner foil seal imprinted with âsealed for your protectionâ is broken or missing distributed by: gsk consumer healthcare, warren, nj 07059 ©2016 gsk group of companies or its licensor. all rights reserved. trademarks are owned by or licensed to the gsk group of companies visit us at www.excedrin.com 46177300 46177300_excedrin tension headache_100 ct.jpg
Further Questions:
Questions or comments? 1-800-452-0051
Questions or comments? 1-800-452-0051