Available Formats

• Active ingredient (in each capsule)

  Simethicone 180 mg

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• Purpose

  Antiflatulent

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• Usesfor relief of:

  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas

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• Warnings

  Stop use and ask a doctor if condition persists.

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• PREGNANCY OR BREAST FEEDING

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

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• KEEP OUT OF REACH OF CHILDREN

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

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• Directions

  • swallow 1 or 2 softgels as needed after meals
  • do not exceed 2 softgels per day unless directed by doctor

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• 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

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• Inactive ingredients

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

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

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• PRINCIPAL DISPLAY PANEL - Shipping Label

  SIMETHICONE CAPSULES,180 mg

  Quantity : 25000 Capsules
  NDC. No : 53345-003-03

  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"

  

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• INGREDIENTS AND APPEARANCE

  GAS RELIEF ULTRA STRENGTH  simethicone 180 mg capsule, liquid filled

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-003 Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE) DIMETHICONE 410 180 mg

  Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4)   FD&C YELLOW NO. 6 (UNII: H77VEI93A8)   GELATIN (UNII: 2G86QN327L)   GLYCERIN (UNII: PDC6A3C0OX)   WATER (UNII: 059QF0KO0R)

  Product Characteristics Color orange Score no score Shape CAPSULE (oval) Size 11mm Flavor Imprint Code PC3 Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-003-03 1 in 1 BOX 1 25000 in 1 BAG

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 04/15/2013

  Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)

  Establishment
  Name	Address	ID/FEI	Business Operations
  Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(53345-003) , ANALYSIS(53345-003)

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