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

• IN CASE OF OVERDOSE, 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

.

Overbagged with 10 chewable tablets per bag, NDC: 55154-2606-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58749200924

LB81210X09

Principal Display Panel

NDC: 55154-2606-0

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, UNSPECIFIED - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	80 mg

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

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)