Otc - Active Ingredient
Calcium carbonate 750 mg
Simethicone 80 mg
Tropical Panned
FDA Label NDC 52642-225
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 Tropical Panned (NDC 52642-225). 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 for the relief of:
- Acid indigestion
- Heartburn
- Sour stomach
- Upset stomach associated with these symptoms
- Bloating, pressure, or stuffed feeling commonl referred to as gas
Warnings
Warnings
Do not use if you've 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 supervsion 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
- Adutls and children 12 years and older: Fully chew then swallow 1 or 2 chewable tablets are 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 330 mg
- store at room temperature. Avoid excessive heat above 40C (104F)
- Close cap tightly after use
Inactive Ingredient
Inactive ingredients
acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C Red #40 Aluminum Lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, methyl paraben, modified starch, potassium hydroxide, pregelatinized modified starch, propyl paraben, propylene glycol, shellac, sorbic acid, sorbitol, sugar, titanium dioxide, triacetin, water, white wax
Otc - Questions
Questions
1-800-986-0369
* Please review the disclaimer below.
