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 125 mg

Active ingredient (in each softgel)

Simethicone 125 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 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

  • store at room temperature 15º - 30ºC

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

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE SOFTGELS, USP 125 mg

Quantity : 28000 Capsules
NDC. No : 11788-031-00

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 125mg

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULE (oval) Size10mm
FlavorImprint Code AP31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11788-031-001 in 1 BOX09/01/2017
128000 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(11788-031) , analysis(11788-031)

Revised: 5/2021
Document Id: c3299df7-08bc-db59-e053-2995a90a6285
Set id: 60ef2673-a586-4a4b-a44a-234968e75478
Version: 5
Effective Time: 20210525
 
AiPing Pharmaceutical, Inc.