NDC 70264-014 Alka-seltzer Original

Product Information

Alka-seltzer Original is product labeled by R J General Corporation. The product's dosage form is and is administered via form.

Product Code70264-014
Proprietary Name 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.
Alka-seltzer Original
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
R J General Corporation
Labeler Code70264
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-02-2010
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

What are the uses for Alka-seltzer Original?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)25 MM
Imprint(s)ALKA;SELTZER
Score1

Product Packages

NDC 70264-014-01

Package Description: 50 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What are Alka-seltzer Original Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Active Moiety)
  • ASPIRIN (UNII: R16CO5Y76E)
  • ASPIRIN (UNII: R16CO5Y76E) (Active Moiety)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • BICARBONATE ION (UNII: HN1ZRA3Q20) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1536675 - aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet
  • RxCUI: 1536675 - ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet
  • RxCUI: 1536680 - Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral Tablet
  • RxCUI: 1536680 - aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]
  • RxCUI: 1536680 - Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral Tablet

* Please review the disclaimer below.

Patient Education

Sodium Bicarbonate

Sodium Bicarbonate is pronounced as (soe' dee um) (bye kar' bon ate)

Why is sodium bicarbonate medication prescribed?
Sodium bicarbonate is an antacid used to relieve heartburn and acid indigestion. Your doctor also may prescribe sodium bicarbonate to make your blood or urine less acidic...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.This medication is sometimes prescribed for other uses;...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Aspirin

Aspirin is pronounced as (as' pir in)
Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]
Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)
Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]

* Please review the disclaimer below.

Alka-seltzer Original Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981


Otc - Purpose



Active ingredients (in each tablet)Purpose
Anhydrous citric acid 1000 mgAntacid
Aspirin 325 mg (NSAID)

nonsteroidal anti-inflammatory drug

Analgesic
Sodium bicarbonate (heat-treated) 1916 mgAntacid

Uses



for the temporary relief of:

  • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
  • upset stomach with headache from overindulgence in food or drink
  • headache, body aches, and pain alone

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



Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • 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
  • 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 are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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
  • you have a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • taking a prescription drug for diabetes, gout, or arthritis

Otc - When Using



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
    • symptoms get worse or last more than 10 days
    • redness or swelling is present
    • ringing in the ears or a loss of hearing occurs
    • new symptoms occur

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.


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.


Other Information



  • each tablet contains: sodium 567 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients



none


Questions Or Comments?



1-800-986-0369 (Mon – Fri 9AM – 5PM EST)


Principal Display Panel - 100 Tablet Pouch Carton



Alka-
Seltzer®

Anhydrous citric acid / Antacid
Aspirin (NSAID) / Analgesic
Sodium bicarbonate / Antacid

Fast Relief of:
Heartburn
Upset Stomach
Acid Indigestion
with Headache
Body Aches

ORIGINAL


* Please review the disclaimer below.