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

Medically reviewed on January 23, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 250mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
NDC Code: 53345-032

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 250 mg, liquid filled

Active ingredient (in each capsule)

Simethicone 250 mg

Purpose

Anti-gas

Uses 
  • relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions
  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information
  • store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, 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, 250 mg

Quantity : 25000 Capsules
NDC. No : 53345-032-01

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:53345-032
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint CodePC31
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-032-011 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(53345-032), ANALYSIS(53345-032)

 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

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Further information

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

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