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Simethicone by AiPing Pharmaceutical, Inc.

Medically reviewed on September 19, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-031

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.

Simethicone Softgels, USP 125 mg

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children

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
  • store at controlled room temperature 20 - 25 ºC (68-77 ºF)
  • protect from light, heat and moisture

TAMPER EVIDENT FEATURE:

Simethicone Softgels, USP 125 mg are sealed in blister packets. Use only if the individual seal in unbroken

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide and white edible ink

Questions or comments?

Call 1-844-374-0016

Principal Display Panel

Manufactured for:

AiPing Pharmaceutical, Inc.

Hauppauge, NY 11788

Manufactured by:

Anshi Pharmaceutical (Zhongshan) Inc., P.R. China

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-031
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
ShapeCAPSULE (oval) Size10mm
FlavorImprint CodeAP31
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-031-121 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/01/2017
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIOperations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-031), analysis(11788-031)

 
AiPing Pharmaceutical, 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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