Active Ingredient(S)
Simethicone 125 mg
Extra Strength Gas Relief Cherry Flavor Tablet, Chewable
FDA Label NDC 53943-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart, Inc for the product Extra Strength Gas Relief Cherry Flavor (NDC 53943-134). 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 active ingredient(s), purpose, use(s), warnings, keep out of the reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Use(S)
relieves:
- Pressure
- bloating
- Symptoms referred to as gas
Warnings
.
Keep Out Of The Reach Of Children.
In case of overdose, get medical help or contact a poison Control Centre immediately.
Directions
- adults and children 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
- do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.
Other Information
- do not use if any individual blister unit is broken or open
- store at room temperature
- avoid high humidity and excessive heat, above 40°C (104°F)
Inactive Ingredients
D&C red #30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.
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Compare to Gas-X® E-X Chewable active ingredient*
NDC 53943-134-39
DISCOUNT drug mart
FOOD FAIR
EXTRA STRENGTH
Gas Relief
Simethicone 125 mg
Fast Acting
Relieves:
- Pressure
- Bloating
- Symptoms Referred to as Gas
Cherry Flavor
36chewable tablets
134chr-36-ddm.jpg (134chr 36 Ddm)
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