SIMETHICONE tablet, chewable

SIMETHICONE by

Drug Labeling and Warnings

SIMETHICONE by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

Warnings

When using this product do not take more than directed, except under the advice of a doctor

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over, chew 1-2 tablets as needed after meals and at bedtime

chew thoroughly

do not exceed 6 tablets in 24 hours

children under 12 years, consult a doctor

Other information

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature, 15°C - 30°C (59˚F - 86˚F)

Inactive ingredients

dextrose, peppermint flavor, silica, sorbitol, stearic acid, talc, calcium phosphate.

package Label

GERICARE

NDC: 57896-791-01

CHEWABLE

SIMETHICONE

TABLETS USP, 80mg

FOR GAS DISTRESS

MINT FLAVOR

100 Tablets

80 mg each

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-791
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	44;137
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-791-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/01/2004

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)