Otc - Active Ingredient
Active ingredients (in each chewable tablet)
Calcium carbonate 750 mg
Simethicone 80 mg
Topcare Cherry Berry Lime Antacid Hbg Tablet, Chewable
FDA Label NDC 76162-408
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 Cherry Berry Lime Antacid Hbg (NDC 76162-408). 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 an allergic reaction to this product or any of its ingredients.
Do not take more than maximum dosage in a 24-hour period, or use the maximum dosage for this product for more than 2 weeks, except unde 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 care 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 every 2-4 hours as needed. Do not exceed 5 chewable tablets in 24 hours. Children under 12 years consult a doctor.
Other Safety Information
Other information
- Each chewable tablet contains: Calcium 300 mg
- Contains FD&C yellow No. 5 (tartrazine) as a color additive
- Contains soy
- 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 blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #5 aluminum lake, FD&C yellow #6 aluminum lake, glycerin, gum arabic, hydrogenated coconut oil, maltodextrin, medium chain triglycerides, natural and artificial flavors, phosphoric acid,
polyvinylpyrrolidone, propylele glycol, shellac, sodium benzoate, sorbitol, soy lecithin, soybean oil, sucrose, titanium dioxide, water.
Otc - Questions
Questions? Call 1-800-245-2898 Monday - Friday, 9AM - 4PM EST
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