SIMETHICONE - dimethicone tablet, chewable 
Geri-Care Pharmaceuticals, Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

For the relief of pressure and bloating 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.

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

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 over 12 years, 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

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

Chewable Simethicone label

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-791
Route of Administration ORAL DEA Schedule     
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
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)

Revised: 12/2013
Document Id: cc0cf0c5-7bdd-4a52-a40b-5615d5706b72
Set id: be96ce05-dd74-4915-9a8f-2a1b34e2f158
Version: 1
Effective Time: 20131204
 
Geri-Care Pharmaceuticals, Corp