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Gas Relief by Physicians Total Care, Inc.

Medically reviewed on May 2, 2018

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-2860

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.

Leader 44-137

Active ingredients

 Simethicone 80 mg

Purpose

 Antigas

Use(s)

 relieves these symptoms associated with gas

  • bloating
  • pressure
  • stuffed feeling
  • fullness

Warnings

If pregnant or breast-feeding,

 ask a health professional before use.

Keep out of reach of children.

Directions
  •  do not exceed 6 tablets per day unless directed by a doctor
  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime

Other information
  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF) 

Inactive ingredients

 dextrose, peppermint flavor, silica gel, sorbitol, stearic acid, talc, tri-calcium phosphate

Principal display panel

NDC 54868-2860-0

Simethicone 80 mg

Gas Relief

•Pressure   •Bloating   •Discomfort

Fast Acting

Anti Gas

Mind Flavored

100 Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844  REV1104E13712

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2860(NDC:37205-112)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
SILICON DIOXIDE 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code44;137
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-2860-0100 TABLET, CHEWABLE (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33205/17/1995
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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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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