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Simethicone by AiPing Pharmaceutical, Inc.

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
  • 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 
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:11788-031-001 BAG in 1 BOX
128000 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(11788-031), analysis(11788-031)

Revised: 09/2017
 
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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