Label: MYLICON- simethicone suspension

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 16, 2023

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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 anddispense liquid slowly into baby’s mouth, toward the inner cheek dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
    • clean dropper well after each use and replace original cap on bottle
    Age (years)Weight (lbs)Dose
    infants (under 2)under 240.3 mL

    children (2 and over)

    		24 and over0.6 mL

  • Other information

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

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

  • Questions or comments?

    1-800-540-3765

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • Package Label

    image 1

    image 2

  • INGREDIENTS AND APPEARANCE
    MYLICON 
    simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0799(NDC:57896-798)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MALTITOL (UNII: D65DG142WK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0799-1120 in 1 BOX, UNIT-DOSE04/06/2023
    10.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:17856-0799-2120 in 1 BOX, UNIT-DOSE04/06/2023
    20.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:17856-0799-3120 in 1 BOX, UNIT-DOSE04/06/2023
    30.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    4NDC:17856-0799-4120 in 1 BOX, UNIT-DOSE04/06/2023
    40.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    5NDC:17856-0799-560 in 1 BOX, UNIT-DOSE04/06/2023
    51.2 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33205/01/2014
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0799)
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