Active Ingredient(In Each Tablet)
Simethicone 125 mg
Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 42507-701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Extra Strength Gas Relief (NDC 42507-701). 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(in each tablet), purpose, use(s), warnings, keep out of 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 Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center 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.
Principal Display Panel
HyVee®
Compare to the Active Ingredient in GAS-X® EX Chewable
Extra Strength
Gas Relief
Simethicone / Anti-Gas
Fast Relief of:
- Pressure
- Bloating
- Gas Distress
- Pressure
- Bloating
- Gas Distress
Cherry Flavor
18 CHEWABLE TABLETS
134chr-18-hv.jpg (134chr 18 Hv)
HyVee®
Compare to the Active Ingredient in GAS-X® EX Chewable
Extra Strength
Gas Relief
Simethicone / Anti-Gas
Fast Relief of:
Cherry Flavor
18 CHEWABLE TABLETS
134chr-48-hv.jpg (134chr 48 Hv)
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