MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]

MYLICON INFANTS GAS RELIEF ORIGINAL (SIMETHICONE) EMULSION [INFIRST HEALTHCARE]
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NDC 62372-630-15, 62372-630-30
Set ID 395be942-d883-4bcb-8811-6fe1521d5a92
Category HUMAN OTC DRUG LABEL
Packager Infirst Healthcare
Generic Name
Product Class
Product Number
Application Number PART332
  • 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.
    Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    shake well before using
    find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    remove cap and insert syringe into the bottle
    pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
    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.
    dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
    replace cap tightly to maintain child resistance
    mL = milliliter

    Age (yr)

    Weight (lb)

    Dose (mL)

    infants under 2

    under 24

    0.3

    children over 2

    over 24

    0.6

  • Other information

    tamper evident: do not use if printed seal under cap is broken or missing
    store between 20-25°C (68-77°F)
    do not freeze
    see bottom panel for lot number and expiration date
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

    Questions or comments?

    Call 1-855-848-3284 toll free (English and Spanish)

  • Principal Display Panel

    Infants' Mylicon®

    Simethicone-Antigas

    Gas Relief

    Gently breaks down baby’s gas bubbles

    Original Drops

    Non-staining

    Safe enough to use at every feeding and up to 12 times per day*

    #1 Brand

    Recommended by Pediatricians

    1 Fl. OZ (30ml)

    100 Doses

    Visit us at mylicon.com

    No Alcohol

    No Artificial Flavors

    No Saccharin

    Gluten Free

    Safe enough to use at every feeding and up to 12 times per day*

    Safe enough for even the newest of newborns*

    *use as directed

    Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

    Important: Keep this carton for future reference on full labeling

    Manufactured for

    infirst Healthcare Inc.

    Westport, CT 06880

    ©2015 infirst Healthcare Inc.

    Package Label for 30 mL

    Infants Mylicon Gas relief Original

    Package Label for 15 mL

    Infants Gas Relief Original Drops 15 mL
  • INGREDIENTS AND APPEARANCE
    MYLICON INFANTS GAS RELIEF ORIGINAL 
    simethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62372-630
    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 FORM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    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
    ColorPINK (pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62372-630-301 in 1 CARTON03/31/2015
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:62372-630-151 in 1 CARTON03/31/2015
    215 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 finalpart33203/31/2015
    Labeler - Infirst Healthcare (079159739)

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