Label: ALKA SELTZER- aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
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Contains inactivated NDC Code(s)
NDC Code(s): 53666-100-10, 53666-403-15, 53666-403-33 - Packager: Salimex, S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 9, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Keep out of reach of children
- Uses for the relief of:
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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.
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALKA SELTZER
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53666-403 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION 1916 mg Product Characteristics Color white Score no score Shape ROUND Size 14mm Flavor Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53666-403-15 150 in 1 CASE 1 NDC:53666-403-33 12 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 10/10/2012 ALKA SELTZER
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53666-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION 1916 mg Product Characteristics Color white Score no score Shape ROUND Size 14mm Flavor Imprint Code ALKA;SELTZER Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53666-100-10 100 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 10/10/2012 Labeler - Salimex, S.A. (589201581) Establishment Name Address ID/FEI Business Operations Bayer de Mexico, S.A. de CV 588165709 manufacture(53666-403)
