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

Medically reviewed on June 18, 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

Drug Facts

Active ingredient (in each softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

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

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

PRINCIPAL DISPLAY PANEL - Shipping Label

Simethicone Capsules 250 mg

NDC 53345-032-02

Quantity: 12 Capsules per blister  

               124 Blisters per box

IMPORTANT:

  1. Inspect immediately 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
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
Colorpurple (clear) Scoreno score
Shapecapsule (oval) Size13mm
FlavorImprint CodePC31
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-032-02124 BLISTER PACK in 1 BOX
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33206/30/2016
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(53345-032), analysis(53345-032)

 
Humanwell PuraCap Pharmaceutical (Wuhan) Co., 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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