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

Medically reviewed on July 25, 2018

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 180mg
Labeler: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
NDC Code: 53345-036

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 180 mg

Active ingredient (in each capsule)

Simethicone 180 mg

Purpose

Anti-gas

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

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children

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

Other information
  • store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

PRINCIPAL DISPLAY PANEL - Shipping Label

SIMETHICONE CAPSULES, 180 mg

Quantity : 25000 Capsules
NDC. No : 53345-036-01

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:53345-036
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
Colororange (clear) Scoreno score
Shapecapsule (oval) Size10mm
FlavorImprint Code667
Contains    
Packaging
#Item CodePackage Description
1NDC:53345-036-011 BAG in 1 BOX
125000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/25/2016
Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(53345-036), analysis(53345-036)

 
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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