FDA Label for Simethicone

View Indications, Usage & Precautions

Simethicone Product Label

The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)



Simethicone 180 mg


Purpose



Anti-gas


Uses



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

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 59° - 86°F (15° - 30°C)

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:

  • Inspect immediate upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)
  • CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


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