QUITA COLICOS GAS RELIEF DROPS (SIMETHICONE) LIQUID [DLC LABORATORIES, INC.]

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QUITA COLICOS GAS RELIEF DROPS (SIMETHICONE) LIQUID [DLC LABORATORIES, INC.]
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NDC 24286-1533-8
Set ID d4b0fa36-5925-4a6f-b3c9-0c785503976f
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    • only use the enclosed dropper. Fill dropper to the recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek.
    • all dosages may be repeated as needed, after meals and at bedtime or as directed by a doctor
    • do not exceed 12 doses per day
    • 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

    mL = milliliter

  • Other information

    • do not use if printed bottle wrap is missing or broken
    • store at room temperature
    • do not freeze
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    citric acid, hydroxypropyl methylcellulose, maltitol, natural flavor, purified water USP, sodium benzoate, sodium citrate, xanthan gum

  • SPL UNCLASSIFIED SECTION

    INFANTS (under 2 years): 0.3 mL

    Image

    CHILDREN (over 2 years): 0.6 mL

    AGE (years)WEIGHT (lbs.)DOSE
    INFANTS under 2Under 24 lbs.0.3 mL
    CHILDREN over 2More than 24 lbs.0.6 mL
  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

    De La Cruz®
    Baby

    Gas
    Relief Drops

    Gotas Quita Cólicos®

    Simethicone
    — ANTIGAS —

    Safe for newborns & infants
    No alcohol, No dyes, No saccharin

    Up To 100 Doses

    NATURAL
    CHERRY FLAVOR

    1 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    QUITA COLICOS GAS RELIEF DROPS 
    simethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1533
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTITOL (UNII: D65DG142WK)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1533-81 in 1 BOX03/18/2014
    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 FINALpart33203/18/2014
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1533) , LABEL(24286-1533)
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