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Simethicone by Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Medically reviewed on April 9, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
NDC Code: 53345-009

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 CAPSULES 125 mg, liquid filled

Active ingredient (in each capsule)

Simethicone 125 mg

Purpose

Antiflatulent

Uses for relief of:
  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime
  • do not exceed 4 softgels per day unless directed by doctor

Other information
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules
NDC. No : 53345-009-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULE (OVAL) Size9mm
FlavorImprint CodePC2
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-009-011 BAG (BAG) in 1 BOX
125000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/15/2013
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-009), ANALYSIS(53345-009)

 
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

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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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