ACTIVE INGREDIENT (IN EACH TABLET)

SIMETHICONE 80MG

PURPOSE

ANTI-GAS

GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

KEEP OUT OF REACH OF CHILDREN.

ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE

01b LBL_Simethicone_80mg_100 tablets

SIMETHICONE 80MG
simethicone tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77333-812-10	100 in 1 BOX	10/15/2022
1	NDC:77333-812-25	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M002	09/02/2022

Labeler - Gendose Pharmaceuticals, LLC (080257510)