SIMETHICONE 80MG- simethicone tablet, chewable

SIMETHICONE 80MG by

Drug Labeling and Warnings

SIMETHICONE 80MG by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 107, LLC, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH TABLET)

SIMETHICONE 80MG

PURPOSE

ANTI-GAS

USES

• RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT

WARNINGS

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

• 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.

OTHER INFORMATION

• EACH TABLET CONTAINS: CALCIUM 60MG
• STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

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

Generic Section

Distributed by:

GenDose Pharmaceuticals

Huntersville, NC 28078

Distributed By:

Cardinal Health

Dublin, OH 43017

L58749200924

Principal Display Panel

Simethicone 80mg

Chewable Tablets

10 Chewable Tablets

INGREDIENTS AND APPEARANCE

SIMETHICONE 80MG 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-2606(NDC:77333-812)
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	15mm
Flavor		Imprint Code	RP111
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-2606-0	10 in 1 BAG	10/01/2024
1		1 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	10/01/2024

Labeler - Cardinal Health 107, LLC (118546603)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	REPACK(55154-2606)