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Simethicone by AiPing Pharmaceutical, Inc.

Medically reviewed on Sep 21, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: AiPing Pharmaceutical, Inc.
NDC Code: 11788-032

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 180 mg

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses
  • 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 2 softgels in 24 hours except under the advice and supervision of a physician

Other information
  • store at room temperature 15º - 30ºC

Inactive ingredients

FD&C Yellow No. 6, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide and white edible ink

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE SOFTGELS, USP 180 mg

Quantity : 21000 Capsules
NDC. No : 11788-032-00

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (oval) Size11mm
FlavorImprint CodeAP32
Contains    
Packaging
#Item CodePackage Description
1NDC:11788-032-001 BAG in 1 BOX
121000 CAPSULE, LIQUID FILLED in 1 BAG
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(11788-032), analysis(11788-032)

 
AiPing Pharmaceutical, Inc.

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Further information

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

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