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Drug Facts
Alka-seltzer Heartburn Relief Extra Strength Tablet, Effervescent
FDA Label NDC 0280-0079
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc for the product Alka-seltzer Heartburn Relief Extra Strength (NDC 0280-0079). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Anhydrous citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1976 mg
Otc - Purpose
Antacid
Antacid
Indications & Usage
Uses for the relief of
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Warnings
Warnings
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if you have a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - When Using
When using this product do not exceed recommended dosage
Otc - Stop Use
Stop use and ask a doctor if you have taken the maximum dose for 2 weeks
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
● fully dissolve 2 tablets in 4 ounces of water before taking
| adults and children 12 years and over | 2 tablets every 4 hours as needed, or as directed by a doctor | do not exceed 8 tablets in 24 hours |
| adults 60 years and over | 2 tablets every 4 hours as needed, or as directed by a doctor | do not exceed 4 tablets in 24 hours |
| children under 12 years | consult a doctor |
Other Safety Information
Other information
● each tablet contains: sodium 586 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Extra Strength in water contains the antacid
sodium citrate as the principal active ingredient
Inactive Ingredient
Inactive ingredients
magnesium stearate, mannitol
Otc - Questions
Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
Package Label.Principal Display Panel
ALKA-SELTZER
Fast 4-in-1
Relief of:
Heartburn
Sour Stomach
Acid Indigestion
Upset Stomach
HEARTBURN RELIEF
EXTRA STRENGTH
24 EFFERVESCENT TABLETS
(12 - 2 count pouches)
Alkaseltzerhres (Alkaseltzerhres)
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