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EXTRA STRENGTH GAS RELIEF by Geri-Care Pharmaceuticals, Corp

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Geri-Care Pharmaceuticals, Corp
NDC Code: 57896-792

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 softgel)

Simethicone 125 mg

Purpose

Anti-Gas

Use

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

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: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at controlled room temperature

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, sorbitol special, titanium dioxide, water

package label

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-792
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
SORBITOL 
WATER 
D&C YELLOW NO. 10 
GELATIN 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
GLYCERIN 
PEPPERMINT OIL (PEPPERMINT)  
MANNITOL 
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize9mm
FlavorImprint CodeIS05
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-792-0550 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/2017
Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

 
Geri-Care Pharmaceuticals, Corp

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Medically reviewed on Dec 25, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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