Label: MYLANTA GAS MAXIMUM STRENGTH- dimethicone tablet, chewable
- NDC Code(s): 16837-861-24
- Packager: McNeil Consumer Pharmaceuticals Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Simethicone 125 mgClose
- relieves bloating, pressure, and discomfort of gas which can be caused by certain foods (such as beans, bran, and broccoli) or air swallowing
- thoroughly chew 1-2 tablets as needed after meals and at bedtime
- do not exceed 4 tablets per day unless directed by a physician
- Other information
- each tablet contains: calcium 66 mg
- store between 20-25°C (68-77°F). Avoid high humidity.
- do not use if carton or any blister unit is open or broken
- Inactive ingredients
D&C red no. 7 calcium lake, dextrates, flavors, magnesium stearate, modified starch, silicon dioxide, tribasic calcium phosphateClose
- Questions or comments?
call 1-800-469-5268 (toll-free) or 215-273-8755 (collect)Close
- PRINCIPAL DISPLAY PANEL
SIMETHICONE • ANTI-GAS
24 TABLETS-125 mg each
- INGREDIENTS AND APPEARANCE
MYLANTA GAS MAXIMUM STRENGTH
dimethicone tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16837-861 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 125 mg Inactive Ingredients Ingredient Name Strength DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 16mm Flavor CHERRY Imprint Code MYL;GAS;125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16837-861-24 4 in 1 CARTON 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 06/01/1996 06/30/2015 Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)