ALKA SELTZER- aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent 
Salimex, S.A.

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.

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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:

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:

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

Other information

Inactive ingredients

None

Questions or comments?

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
or www.alkaseltzer.com

image description

ALKA SELTZER 
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-403
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION1916 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint Code ALKA;SELTZER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53666-403-15150 in 1 CASE
1NDC:53666-403-3312 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION1916 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint Code ALKA;SELTZER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53666-100-10100 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/FEIBusiness Operations
Bayer de Mexico, S.A. de CV588165709manufacture(53666-403)

Revised: 11/2012
Document Id: c5cec0f6-56ff-4544-a932-a133ad26c2d4
Set id: 73e85be6-1236-453b-b41c-37381a054773
Version: 3
Effective Time: 20121109
 
Salimex, S.A.