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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Bitterfeld Gmbh for the product Alka-seltzer Original (NDC 65662-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active Ingredients | Purpose |
| (in each tablet) | |
| Anydrous citic acid 100mg | Antacid |
| Aspirin 325 mg (NSAID)* | Analgesic |
Sodium bicarbonate (heat-treated) 1916 mg *nonsteroidal anti-inflammatory drug | Antacid |
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
Warnings
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:
Stomach bleeding warning: This product contains an NSAID, which may cuase severe stomach bleeding. The chance is higher if you
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before us. It is especially important not to use aspirin during the last 3 months of pregnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complicaitons during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| 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
Inactive ingredients none
Questions or comments? 1-800-986-0369
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Alka-Seltzer® Original
Anhydrous citric acid / Antacid
Aspirin (NSAID) / Analgesic
Sodium bicarbonate / Antacid
Fast Relief of:
Heartburn
Upset Stomach
Acid Indigestion
with Headache
Body Aches
12 EFFERVESCENT TABLETS
* Please review the disclaimer below.