Otc - Active Ingredient
Active ingredient (in each chewable tablet)
Calcium carbonate 750 mg
Alka Seltzer
FDA Label NDC 52642-226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bestco Inc. for the product Alka Seltzer (NDC 52642-226). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antacid
Indications & Usage
Uses for the relief of:
- acid indigestion
- heartburn
- sour stomach
- upset stomach associated with these symptoms
Warnings
Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients
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 take more than 5 chewable tablets in a 24-hour period
- do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
- constipation may occur
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
- adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor
- children under 12 years: consult a doctor
- do not take more than 5 chewable tablets in a 24-hour period
Other Safety Information
Other information
- each chewable tablet contains: calcium 300 mg
- contains FD&C Yellow No. 5 (tartrazine) as a color additive
- store at room temperature. Avoid humidity.
- close cap tightly after use.
Inactive Ingredient
Inactive ingredients
acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, DL-alpha tocopherol, FD&C blue #1 aluminum lake, FD&C yellow #5 lake (tartrazine), FD&C yellow #6, FD&C yellow #6 aluminum lake, FD&C yellow #6 lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, medium chain triglycerides, methyl paraben, modified starch, phosphoric acid, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sugar, titanium dioxide, water, white wax
Otc - Questions
Questions or comments?
1-800-986-0369 (Mon-Fri 9AM-5PM EST)
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