Label: SIMETHICONE- simethicone tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 8, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Each tablet contains 80 mg Simethicone

    Mint Flavored chewable tablets

    Close
  • Purpose

    Anti-gas

    Close
  • Keep Out of Reach of Children

    Keep this and all drugs out of the reach of children.

    Close
  • Uses

    Relieves pressure, bloating, and symptoms referred to as gas.

    Close
  • Warnings

    This package is intended for institutional use only.

    Do not exceed six tablets in a 24 hour period except under the advice and supervision of a physician.

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

    Close
  • Directions

    Chew one or two tablets thoroughly as needed after meals and at bedtime.

    Close
  • Inactive ingredients

    Compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin and sorbitol.

    Close
  • Storage

    STORE at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F).

    Mint Flavored chewable Tablets

    Sky

    Mfg. By: Guardian Drug Company

    2 Charles Court

    Dayton, NJ 08810

    Distributed By

    McKesson Packaging Services

    a business unit of McKesson Corporation

    7101 Weddington Road

    Concord, NC 28027

    Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

    www.PROmanager-Rx.com

    Repackaged by Cardinal Health

    Zanesville, OH 43701

    L43456330115

    Close
  • Principal Display Panel

    Simethicone Anti-Gas

    80 mg Tablets

    10 Tablets

    bag label
    Close
  • INGREDIENTS AND APPEARANCE
    SIMETHICONE 
    simethicone tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1480(NDC:63739-225)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM (UNII: I38ZP9992A)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code GDC;103
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-1480-0 10 in 1 BAG 06/06/2011
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/06/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK(55154-1480)
    Close