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SIMETHICONE by Geri-Care Pharmaceuticals, Corp

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Geri-Care Pharmaceuticals, Corp
NDC Code: 57896-791

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, 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

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-791
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
SILICON DIOXIDE 
SORBITOL 
STEARIC ACID 
TALC 
TRICALCIUM PHOSPHATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code44;137
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-791-01100 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/2004
Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 12/2017
 
Geri-Care Pharmaceuticals, Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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