NDC 0280-0069 Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night

Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate

NDC Product Code 0280-0069

NDC CODE: 0280-0069

Proprietary Name: Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspirin, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
ASP;DAY
ASP;NT
Score: 1
Flavor(s):
ORANGE (C73406)
LEMON (C73396)

NDC Code Structure

  • 0280 - Bayer Healthcare Llc.
    • 0280-0069 - Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night

NDC 0280-0069-01

Package Description: 1 KIT in 1 CARTON * 1 TABLET, EFFERVESCENT in 1 POUCH * 1 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night with NDC 0280-0069 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night is aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate. The product's dosage form is kit and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1536498, 2565491 and 2565492.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MANNITOL (UNII: 3OWL53L36A)
  • POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • CALCIUM SILICATE (UNII: S4255P4G5M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONE (UNII: FZ989GH94E)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CALCIUM SILICATE (UNII: S4255P4G5M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bayer Healthcare Llc.
Labeler Code: 0280
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-05-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Product Label Images

Alka-seltzer Plus Severe Cold Powerfast Fizz Day And Night Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug FactsAlka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

Otc - Active Ingredient

Active ingredients (in each tablet) PurposesAspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg……………………Cough suppressantPhenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant*nonsteroidal anti-inflammatory drug

Active ingredients (in each tablet) PurposesAspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducerDextromethorphan hydrobromide 10 mg……..…..……Cough suppressantDoxylamine succinate 6.25 mg………………..…..………...…AntihistaminePhenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant*nonsteroidal anti-inflammatory drug

Indications & Usage

  • Uses temporarily relieves these symptoms due to a cold with cough:
  • Minor aches and painsheadachesinus congestion and pressurecoughsore throatnasal congestiontemporarily reduces fever

  • Uses temporarily relieves these symptoms due to a cold:
  • Minor aches and pains headache runny nose sinus congestion and pressure cough sneezingsore throat nasal congestiontemporarily reduces fever

Warnings

WarningsReye’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: Aspirin may cause a severe allergic reaction which may include:
· hives · facial swelling · asthma (wheezing) · shockStomach 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 directedSore 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.

  • WarningsReye’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: Aspirin may cause a severe allergic reaction which may include:
  • Hivesfacial swelling ·asthma (wheezing)shockStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • Are age 60 or olderhave had stomach ulcers or bleeding problemsartake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedSore 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.

Otc - Do Not Use

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 itsingredients● in children under 12 years of age

  • Do not useif you are allergic to aspirin or any other pain reliever/fever reducerif 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 ingredientsin children under 12 years of age

Otc - Ask Doctor

  • Ask a doctor before use ifstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have
  • Asthma •thyroid •disease diabetescough that occurs with excessive phlegm (mucus)difficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemaa sodium-restricted diet

  • Ask a doctor before use ifstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have
  • Asthmadiabetesthyroid diseaseglaucomacough that occurs with excessive phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisdifficulty in urination due to enlargement of the prostate glandpersistent or chronic cough such as occurs with smoking, asthma,or emphysemaa sodium-restricted diet

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking a prescription drug for
  • Goutdiabetesarthritis

  • Ask a doctor or pharmacist before use if you aretaking a prescription drug for
  • Goutdiabetesarthritistaking sedatives or tranquilizers

Otc - When Using

When using this product do not exceed recommended dosage.

  • When using this productdo not exceed recommended dosagemay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Otc - Stop Use

  • Stop use and ask a doctor ifan allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding
  • Feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurringing in the ears or loss of hearing occurscough comes back or occurs with rash or headache that lasts. Thesecould be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

  • Stop use and ask a doctor ifan allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding
  • Feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain, cough, or nasal congestion gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurringing in the ears or loss of hearing occurscough comes back or occurs with rash or headache that lasts. Thesecould be signs of a serious condition.nervousness, dizziness, or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

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.

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsdo not take more than the recommended dosedo 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

  • Directionsdo not take more than the recommended dosedo not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night productadults 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

Other Safety Information

  • Other informationeach tablet contains: potassium 78 mg; sodium 356 mg
  • Store at room temperature. Avoid excessive heat.

  • Other informationeach tablet contains: potassium 78 mg; sodium 356 mg
  • Store at room temperature. Avoid excessive heat.

Inactive Ingredient

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

Otc - Questions

Questions or comments? 1-800-986-0369
(Mon – Fri 9AM – 5PM EST)

Questions or comments? 1-800-986-0369 (Mon-
Fri 9AM – 5PM EST)

* Please review the disclaimer below.