Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

Bayer Healthcare Llc.
Human Otc Drug
NDC 0280-0086

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night also known as Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate is a human otc drug labeled by 'Bayer Healthcare Llc.'. National Drug Code (NDC) number for Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night is 0280-0086. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night drug includes . The currest status of Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night drug is Active.

Drug Information:

Drug NDC:	0280-0086
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 Powerfast Fizz Day And Night
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:	Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bayer Healthcare 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:	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:	27 Apr, 2022
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:	Bayer HealthCare LLC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1536498 2565491 2565492
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.
UPC:	0016500594604
UPC stands for Universal Product Code.
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
0280-0086-01	1 KIT in 1 CARTON (0280-0086-01) * 1 TABLET, EFFERVESCENT in 1 POUCH * 1 TABLET, EFFERVESCENT in 1 POUCH	29 Apr, 2022	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.

Other medicines with the same generic name

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

Kit
Bayer HealthCare LLC.
NDC: 0280-0069

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

Kit
Bayer HealthCare LLC.
NDC: 0280-0086

Alka Seltzer Plus Cold Day And Night Effervescent

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

Tablet
Sincronia Logistica, S.A. de C.V.
NDC: 71992-154

Purpose:

Product Elements:

Alka-seltzer plus severe cold powerfast fizz day and night aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate alka-seltzer plus severe cold powerfast fizz non drowsy asprin, dextromethorphan hydrobromide, phenylephrine bitartrate anhydrous citric acid mannitol potassium bicarbonate povidone sodium bicarbonate aspirin aspirin dextromethorphan hydrobromide dextromethorphan phenylephrine bitartrate phenylephrine calcium silicate fd&c red no. 40 fd&c yellow no. 6 sucralose dimethicone asp alka-seltzer plus severe cold night powerfast fizz aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate mannitol povidone dimethicone calcium silicate anhydrous citric acid doxylamine succinate doxylamine dextromethorphan hydrobromide dextromethorphan sucralose sodium bicarbonate aspirin aspirin phenylephrine bitartrate phenylephrine potassium bicarbonate asp;nt

Indications and Usage:

Uses temporarily relieves these symptoms due to a cold with cough: minor aches and pains headache sinus congestion and pressure cough sore throat nasal congestion temporarily reduces fever

Uses temporarily relieves these symptoms due to a cold: minor aches and pains headache runny nose sinus congestion and pressure cough sneezing sore throat nasal congestion temporarily reduces fever

Warnings:

ore 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 â if you are allergic to aspirin or any other pain reliever/fever reducer â 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. â if you have ever had an allergic reaction to this product or any of itsingredients â in children under 12 years of age ask a doctor before use if 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 â¢thyroid â¢disease diabetes cough that occurs with excessive phlegm (mucus) 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 a prescription drug for gout diabetes arthritis when using this product do not exceed recommended dosage. 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 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with 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. it is especially important not to use aspirin during the last 3 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.

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 if you are allergic to aspirin or any other pain reliever/fever reducer 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 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 diabetes thyroid disease glaucoma cough that occurs 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 a prescription drug for gout diabetes arthritis 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 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 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with 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. it is especially important not to use aspirin during the last 3 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.

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: aspirin may cause a severe allergic reaction which may include: Â· hives Â· facial swelling Â· asthma (wheezing) Â· shock stomach bleeding warning : this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you â are age 60 or older â have had stomach ulcers or bleeding problems â take a blood thinning (anticoagulant) or steroid drug â take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) â have 3 or more alcoholic drinks every day while using this product â take more or for a longer time than directed 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 â if you are allergic to aspirin or any other pain reliever/fever reducer â 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. â if you have ever had an allergic reaction to this product or any of itsingredients â in children under 12 years of age ask a doctor before use if 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 â¢thyroid â¢disease diabetes cough that occurs with excessive phlegm (mucus) 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 a prescription drug for gout diabetes arthritis when using this product do not exceed recommended dosage. 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 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with 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. it is especially important not to use aspirin during the last 3 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.

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 : aspirin may cause a severe allergic reaction which may include: hives facial swelling Â· asthma (wheezing) shock 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 artake 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 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 if you are allergic to aspirin or any other pain reliever/fever reducer 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 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 diabetes thyroid disease glaucoma cough that occurs 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 a prescription drug for gout diabetes arthritis 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 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 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with 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. it is especially important not to use aspirin during the last 3 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.

When Using:

When using this product do not exceed recommended dosage.

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 do not take the day and night products at the same time; wait 4 hours after taking the last night dose before taking the day product adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. do not exceed 4 tablets in 12 hours or as directed by a doctor. children under 12 years: do not use

Directions do not take more than the recommended dose do not take the day and night products at the same time; wait 4 hours after taking the last day dose before taking the night product adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. do not exceed 4 tablets in 12 hours or as directed by a doctor. children under 12 years: do not use

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 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 ringing in the ears or loss of hearing occurs cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs

Package Label Principal Display Panel:

Alka-seltzer plusÂ® severe cold day/citrus night lemon powerfast fizzâ¢ day non-drowsy aspirin (nsaid) /pain reliever - fever reducer dextromethorphan hbr/cough suppressant phenylephrine bitartrate/nasal decongestant nasal decongestant headache + body ache cough sore throat sinus pressure 12 effervescent tablets new night dosing directions night aspirin (nsaid) /pain reliever-fever reducer dextromethorphan hbr/cough suppressant doxylamine succinate/antihistamine phenylephrine bitartrate/nasal decongestant nasal congestion headache + body ache cough runny nose sore throat 8 effervescent tablets carton 20 count

Further Questions:

Questions or comments? 1-800-986-0369 (mon â fri 9am â 5pm est)

Questions or comments? 1-800-986-0369 (mon- fri 9am â 5pm est)

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.