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  5. Label Information: Extra Strength Gas Relief

FDA Label for Extra Strength Gas Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. ADDITIONAL INFORMATION
    12. PRINCIPAL DISPLAY PANEL

Extra Strength Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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.

Other



Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Made in India


Active Ingredient (In Each Softgel)



Simethicone 125 mg


Purpose



Antigas


Uses



for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings




Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information



  • store at controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat, and moisture

Inactive Ingredients



FD & C Blue #01, D&C Yellow #10, gelatin, glycerin, sorbitol solution, titanium dioxide


Questions Or Comments?



1-800-373-6981


Additional Information



Extra Strength Gas ReliefSoftgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

Extra Strength Gas ReliefSoftgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


Principal Display Panel



ValuRx

Compare to the active ingredient in Extra Strength Gas-X®

Extra Strength
Gas Relief
Simethicone 125 mg
Antigas

Relieves Gas Fast

  • Pressure
  • Bloating
  • Discomfort

    • Carton


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