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Anti Gas Extra Strength

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Allegiant Health
NDC Code: 69168-243

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.

Drug Facts

Active ingredient

Simethicone 125 mg

Purpose

Antigas

Uses

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

Warnings

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Keep Out of Reach of Children

[Enter Keep Out of Reach of Children here]

Directions

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

Inactive Ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, titanium dioxide

Package/Label Principal Display Panel
ANTI GAS  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-243
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-243-2715 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/16/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-243), LABEL(69168-243), MANUFACTURE(69168-243), PACK(69168-243), RELABEL(69168-243), REPACK(69168-243)

Revised: 12/2014
 
Allegiant Health

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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