![ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]](https://medic.hrt.org//dailymed/images/73e85be6-1236-453b-b41c-37381a054773/Alka-Seltzer.jpg)
| NDC | 53666-100-10, 53666-403-15, 53666-403-33 |
| Set ID | 73e85be6-1236-453b-b41c-37381a054773 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Salimex, S.A. |
| Generic Name | |
| Product Class | Anti-coagulant |
| Product Number | |
| Application Number | PART343 |
- Active Ingredients (in each tablet)
- Purpose
- Keep out of reach of children
- 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.
Close - 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?
- 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) CloseEstablishment Name Address ID/FEI Business Operations Bayer de Mexico, S.A. de CV 588165709 manufacture(53666-403)