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Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Heartburn And Pain (NDC 0280-0160). 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 - purpose, uses, reye's syndrome, allergy alert, stomach bleeding warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Anhydrous citric acid 1000 mg | Antacid |
| Aspirin 325 mg (NSAID)
nonsteroidal anti-inflammatory drug | Analgesic |
| Sodium bicarbonate (heat-treated) 1916 mg | Antacid |
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.
Aspirin may cause a severe allergic reaction which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.
When using this product do not take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking
● Do not exceed recommended dose. SEE WARNINGS
| 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 |
none
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