Otc - Active Ingredient
Active ingredient (in each chew)
Calcium Carbonate 750 mg
Antacid Flavor Chews Tablet, Chewable
FDA Label NDC 0363-1083
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 Flavor Chews (NDC 0363-1083). 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, 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
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 or pharmacist before use if you are now taking a presciption drug. Antacids may interact with certain prescripton drugs.
Do not take more than 2 weeks, except under the advice and supervision of a physician.
When using this product 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 older chew and swallow 2 to 4 chews, hourly if needed. Do not exceed 5 chews in 24 hours. children under 12 years consult a doctor.
Inactive Ingredient
Inactive ingredients Beeswax, carmine, carnauba wax, citric acid, corn syrup, DL-alpha tocopherol, ethyl acetate, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 lake (tartrazine), FD&C yellow no. 6, FD&C yellow no. 6 aluminum lake, gum arabic, hydrogenated coconut oil, medium chain triglycerides, methyl paraben, modified corn starch, natural and artificial flavors, pregelatinized corn starch, propylene glycol, propyl paraben, phosphoric acid, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide. Soybean oil and corn starch used as processing aids.
Other Safety Information
Other information
Each chew contains: calcium 300 mg, magnesium 1 mg
Contains Soy
Store between 20° to 25°C (68° to 77°F) in a dry place
Otc - Questions
Questions? Or to report an adverse event call 1-800-245-2598 Monday - Friday, 9AM - 4PM EST
* Please review the disclaimer below.
