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Simethicone by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 125mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
NDC Code: 53345-033

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

Antigas

Uses 

for 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 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules
NDC. No : 53345-033-01

IMPORTANT:

  1. Inspect immediate upon receipt.
  2. This is a bulk shipment, intended for further processing only.
  3. Protect from heat, humidity, and light. Do not refrigerate.
  4. Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

SIMETHICONE 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-033
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
D&C YELLOW NO. 10 
GELATIN 
GLYCERIN 
PEPPERMINT OIL 
WATER 
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULE (OVAL) Size10mm
FlavorImprint Code664
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-033-011 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 finalpart33201/28/2015
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(53345-033), ANALYSIS(53345-033)

 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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Medically reviewed on Jan 23, 2018

Further information

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

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