SIMETHICONE- simethicone capsule, liquid filled 
AiPing Pharmaceutical, Inc.

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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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 180mg

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (oval) Size11mm
FlavorImprint Code AP32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11788-032-001 in 1 BOX09/01/2017
121000 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/01/201712/31/2019
Labeler - AiPing Pharmaceutical, Inc. (079674526)
Establishment
NameAddressID/FEIBusiness Operations
Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-032) , analysis(11788-032)

Revised: 5/2021
Document Id: c3296736-6c71-06eb-e053-2995a90aa08f
Set id: f7c7e5fa-257e-4c5e-b9bf-ebf28c56e26b
Version: 3
Effective Time: 20210525
 
AiPing Pharmaceutical, Inc.