Otc - Active Ingredient
Active ingredients (in each chewable tablet)
Calcium carbonate 750 mg
Simethicone 250 mg
Topcare Max Gas Antacid Plus Anti-gas Chews Tablet, Chewable
FDA Label NDC 76162-407
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco for the product Topcare Max Gas Antacid Plus Anti-gas Chews (NDC 76162-407). 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
Anti-gas
Indications & Usage
Uses Relieves
- Heartburn
- Sour stomach
- Acid indigestion
- Upset stomach due to these symptoms
- Bloating, pressure or stuffed feeling commonly referred to as gas
Warnings
Warnings
Do not use if you have ever had a allergic reaction to the product or any of its ingredients.
Do not take more than 2 chewable tablets in a 24-hour period, or use the maximum dosage for this product for more than 2 weeks, except under the advice and supervision of a physician.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - When Using
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 1 to 2 chewable tablets as symptoms occur. Children under 12 years consult a doctor.
Other Safety Information
Other information
- Each chewable tablets contains: Calcium 300 mg
- Contains soy
- Contains FD&C yellow No. 5 (tartrazine) as a color additive
- Store between 20° to 25°C (68° to 77°F) in a dry place
Inactive Ingredient
Inactive ingredients: Beeswax, carmine, carnauba wax, corn starch, corn syrup, dextrin, ethyl acetate, FD&C bleu no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid, propylene glycol, shellac, sodium benzoate, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, water.
Otc - Questions
Questions? Call 1-800-245-2898 M - F, 9AM - 4PM EST
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