Otc - Active Ingredient
Active ingredient (in each chew)
Calcium carbonate 1177 mg
Antacid Soft Chew Tablet, Chewable
FDA Label NDC 0363-1081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Antacid Soft Chew (NDC 0363-1081). 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 - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, 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: Relieves
heartburn
sour stomach
acid indigestion
upset stomach due to these symptoms
Warnings
Warnings
Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain perscription drugs.
Otc - When Using
When using this product do not take more than 6 chews in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.
Otc - Pregnancy Or Breast Feeding
If you are pregnant or nursing a baby, ask a doctor before using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Chew and swallow 2 to 3 chews, as symptoms occur or as directed by a physician.
Other Safety Information
Other information
Each chew contains: calcium 470 mg, magnesium 5 mg
Contains milk and soy
Store between 20° to 25°C (68° to 77°F) in a dry place
Inactive Ingredient
Inactive ingredients: Corn syrup, cory syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural and artificail flavors, non-fat dairy milk powder, soy lecithin and sucrose. Soybean oil and corn starch used as processing aids.
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2898, Monday - Friday, 9AM - 4PM EST
* Please review the disclaimer below.
