EXTRA STRENGTH SIMETHICONE- simethicone tablet, chewable

EXTRA STRENGTH SIMETHICONE by

Drug Labeling and Warnings

EXTRA STRENGTH SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or a Poison Control Center (1-800-222-1222) right away.

Directions

• adults:chew one or two tablets as needed after meals and at bedtime
• do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

Other information

• each tablet contains:calcium 85 mg
• TAMPER EVIDENT:DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture

Inactive ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate.

Questions?

call toll free 1-844-912-4012

Principal Display Panel

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SIMETHICONE 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-233
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	44;608
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-233-18	2 in 1 CARTON	09/01/2025
1		9 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 Drug	M002	09/01/2025

Labeler - Bi-Mart (027630078)

Registrant - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(37835-233)