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Simethicone

Cardinal Health

Simethicone Chewable 80 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

In each tablet: Simethicone 80 mg

Purpose

Antigas

Keep Out of Reach of Children

Keep out of the reach of children.

Simethicone Uses

Relieves pressure and bloating commonly referred to as gas.

Warnings

TAMPER EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing. For institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child resistant container should be utilized.

Directions

Chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. Do not exceed 6 tablets per day unless directed by a physician.

Inactive ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

STORAGE: Store at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F)

Manufactured for

Goldline Laboratories, Inc

Sellersville, PA 18960

By Guardian Drug Company

Dayton, NJ 08810

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Simethicone Chewable Tablets

80 mg

Antigas

10 Tablets

Simethicone

Simethicone

Simethicone TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-8606(NDC:0182-8643)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 80 mg

Inactive Ingredients

Ingredient Name Strength
SUCROSE
DEXTROSE
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
sorbitol

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm GDC;103 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-8606-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-03


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Be sure to consult your doctor before taking any medication!
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