Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz
Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide Tablet, Effervescent
Select Corporation
Human Otc Drug
NDC 52904-830Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz also known as Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide Tablet, Effervescent is a human otc drug labeled by 'Select Corporation'. National Drug Code (NDC) number for Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz is 52904-830. This drug is available in dosage form of Tablet, Effervescent. The names of the active, medicinal ingredients in Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz drug includes Acetaminophen - 250 mg/1 Chlorpheniramine Maleate - 2 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz drug is Active.
Drug Information:
| Drug NDC: | 52904-830 |
| 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: | Alka Seltzer Plus Severe Cold And Flu Powerfast Fizz |
| 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: | Chlorpheniramine Maleate, Acetaminophen, Phenylephrine Hydrochloride, Dextromethorphan Hydrobromide Tablet, Effervescent |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Select Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Effervescent |
| 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: | ACETAMINOPHEN - 250 mg/1
CHLORPHENIRAMINE MALEATE - 2 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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 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: | 03 Jul, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | part341 |
| 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: | Select Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1536477
|
| 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: | 362O9ITL9D
V1Q0O9OJ9Z
9D2RTI9KYH
04JA59TNSJ
|
| 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. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52904-830-04 | 1 POUCH in 1 BLISTER PACK (52904-830-04) / 2 TABLET, EFFERVESCENT in 1 POUCH | 03 Jul, 2017 | N/A | No |
| 52904-830-05 | 2 POUCH in 1 BLISTER PACK (52904-830-05) / 2 TABLET, EFFERVESCENT in 1 POUCH | 03 Jul, 2017 | N/A | No |
| 52904-830-20 | 20 POUCH in 1 CARTON (52904-830-20) / 2 TABLET, EFFERVESCENT in 1 POUCH | 03 Jul, 2017 | N/A | No |
| 52904-830-25 | 25 POUCH in 1 CARTON (52904-830-25) / 2 TABLET, EFFERVESCENT in 1 POUCH | 03 Jul, 2017 | N/A | No |
| 52904-830-30 | 30 POUCH in 1 CARTON (52904-830-30) / 2 TABLET, EFFERVESCENT in 1 POUCH | 03 Jul, 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:
Active ingredients (in each tablet) purposes acetaminophen 250 mg pain reliever/fever reducer chlorpheniramine maleate 2 mg antihistamine dextromethorphan hydrobromide 10 mg cough suppressant phenylephrine hydrochloride 5 mg nasal decongestant
Product Elements:
Alka seltzer plus severe cold and flu powerfast fizz chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine chlorpheniramine maleate chlorpheniramine acesulfame potassium anhydrous citric acid fd&c red no. 40 magnesium stearate maltodextrin mannitol saccharin sodium sodium bicarbonate speckled asp;flu
Indications and Usage:
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat runny nose sneezing nasal and sinus congestion temporarily reduces fever
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg 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 or severe allergic reactions. symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock if a skin or general allergic reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use to sedate children. 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 are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for d
Read more...epression, 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. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium restricted diet ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg 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 or severe allergic reactions. symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock if a skin or general allergic reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use to sedate children. 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 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. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema a sodium restricted diet ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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 do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions do not take more than the recommended dose adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. do not exceed 8 tablets in 24 hours or as directed by a doctor. children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs
Package Label Principal Display Panel:
Principal display panel - 2 tablet pouch blister pack alka- seltzer plus ® acetaminophen / pain reliever-fever reducer chlorpheniramine maleate / antihistamine dextromethorphan hbr / cough suppressant phenylephrine hydrochloride / nasal decongestant severe cold & flu citrus ⢠fever & body ache ⢠cough ⢠nasal congestion ⢠runny nose ⢠sore throat bayer power fast fizz⢠2 effervescent tablets single-pack principal display panel - 2 tablet pouch blister pack
Further Questions:
Questions or comments? 1-800-986-0369 (mon-fri 9am â 5pm est)