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Alka Seltzer by Salimex, S.A.

Medically reviewed on November 9, 2017

Dosage form: tablet, effervescent
Ingredients: ASPIRIN 325mg, ANHYDROUS CITRIC ACID 1000mg, SODIUM BICARBONATE 1916mg
Labeler: Salimex, S.A.
NDC Code: 53666-403

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Alka Seltzer

Active Ingredients
(in each tablet)

Aspirin 325 mg

Citric acid 1000 mg

Sodium Bicarbonate (heat treated) 1916 mg

Purpose

Analgesic, Antacid

Keep out of reach of children

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

Uses for the 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

Warnings

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • asthma (wheezing)

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Directions
  • fully dissolve 2 tablets in 4 ounces of water before taking
  • adults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours
  • adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours
  • children under 12 years consult a doctor

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)
or www.alkaseltzer.com

ALKA SELTZER 
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-403
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (BICARBONATE ION) BICARBONATE ION1916 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint CodeALKA;SELTZER
Contains    
Packaging
#Item CodePackage Description
1NDC:53666-403-15150 BOX in 1 CASE
1NDC:53666-403-3312 TABLET, EFFERVESCENT in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/10/2012
ALKA SELTZER 
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (BICARBONATE ION) BICARBONATE ION1916 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint CodeALKA;SELTZER
Contains    
Packaging
#Item CodePackage Description
1NDC:53666-100-10100 TABLET, EFFERVESCENT in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/10/2012
Labeler - Salimex, S.A. (589201581)
Establishment
NameAddressID/FEIOperations
Bayer de Mexico, S.A. de CV588165709manufacture(53666-403)

 
Salimex, S.A.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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