Label: PREMIER VALUE INFANTS GAS RELIEF- simethicone emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Active ingredient (in each 0.3 mL)

    Simethicone 20 mg

  • Purpose

    Antigas

  • Uses

    relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

  • 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 the inner cheek
    ▪
    dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
    ▪
    clean dropper after each use - replace bottle with original cap

    age (yr)

    weight (lb)

    dose

    infants under 2

    under 24

    0.3 mL

    children over 2

    over 24

    0.6 mL
  • Other information

    ▪
    tamper evident: do not use if printed seal under cap is torn or missing
    ▪
    store at room temperature
    ▪
    do not freeze
    ▪
    see bottom panel for lot and expiration date
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS*

    Premier Value®

    Infants'

    Gas Relief

    Non-Staining formula

    Simethicone 20 mg/Antigas

    •
    Dye Free
    •
    No Saccharin
    •
    No Artificial Colors
    •
    No Artificial flavors

    Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose)

    1 Fl. OZ (30ml)

    100 Doses

    Distributed by

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    *This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.

    Permier Value Infants' Gas Relief

    Premier Value Infants' Gas Relief

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE INFANTS GAS RELIEF 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-670
    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, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (white to off white, opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-670-001 in 1 CARTON01/09/2015
    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 DrugM00201/09/2015
    Labeler - Chain Drug Consortium (101668460)
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