GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [RUGBY LABORATORIES]

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GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [RUGBY LABORATORIES]
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NDC 0536-2220-75
Set ID 2421d17b-8256-4832-8e5a-a96fb7505607
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

  • Purpose

    Antigas

  • Use

    relieves the 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 right away.

  • Directions

    • shake well before using
    • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
    • do not exceed 12 doses per day
    • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
    • may be mixed with 1 oz of water, infant formula or other suitable liquid
    • for best results, clean dropper after each use and replace original cap
    Age (years)Weight (lbs) Dose
    infants (under 2)
    		under 24
    		0.3 mL
    children (over 2)
    		over 24
    		0.6 mL

  • Other information

    • store at room temperature
    • do not freeze
    • see bottom panel for lot number and expiration date
    • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

    Questions or comments?

    1-800-645-2158

  • package Label

    compare to the active ingredient of MYLICON DROPS
    RUGBY

    NDC 0536-2220-75

    GAS RELIEF DROPS
    Simethicone Oral Suspension USP
    Suitable for Infant Use

    Antigas
    Relieves the Symptoms Referred to as Gas
    dye free formula

    1 FL OZ (30 mL)

    rug

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone suspension/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-2220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MALTITOL (UNII: D65DG142WK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (off-white) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-2220-751 in 1 CARTON03/01/2017
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33212/01/2010
    Labeler - Rugby Laboratories (079246066)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0536-2220)
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