1. Home
  2. Labeler Index
  3. Guardian Drug Company
  4. 53041-103
  5. Label Information: Gas Relief

FDA Label for Gas Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH TABLET)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PRINCIPAL DISPLAY PANEL

Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Guardian Drug Company. 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 Tablet)



Simethicone 80 mg


Purpose



Antigas


Use(S)



relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

Warnings



.


Keep Out Of Reach Of Children



In case of overdose, get medical help or contact a Poison Control Center immediately. 


Directions



  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician

Other Information



  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

Inactive Ingredients



compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.


Principal Display Panel



GUARDIAN 

NDC 53041-103-16


*Compare to the Active Ingredient in MYLANTA® GAS

MINT FLAVOR

GAS BAN


ANTI-GAS/
SIMETHICONE

80 mg

Provides Fast Relief of

Pressure, Bloating

& Gas Distress

100 Chewable Tablets (80 mg Ea.)

103-100-gdc.jpg - 103 100 gdc

103-100-gdc.jpg - 103 100 gdc


* Please review the disclaimer below.