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
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Extra Strength (NDC 0280-0211). 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 uses, warnings, do not use, ask a doctor before use if, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
for the temporary relief of:
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 cause severe stomach bleeding. The chance is higher if you
• feel faint • vomit blood
• have bloody or black stools
• have stomach pain that does not get better
| adults and children 12 years and over | 2 tablets every 6 hours, or as directed by a doctor | do not exceed 7 tablets in 24 hours |
| adults 60 years and over | 2 tablets every 6 hours, or as directed by a doctor | do not exceed 3 tablets in 24 hours |
| children under 12 years | consult a doctor | |
flavor
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