BACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]

BACTIMICINA CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [DLC LABORATORIES, INC.]
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NDC 24286-1565-4
Set ID eaf554d4-a758-4ed6-bec5-d6cbfedae408
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • find right dose on chart below
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • mL = milliliter; tsp = teaspoonful
    Age (yr)Dose (mL or tsp)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL (1 tsp) to 10 mL (2 tsp)

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL (1 tsp) contains: sodium 2.3 mg
    • store at room temperature. Protect from light. Store in outer carton until contents used.
    • dosage cup provided
    • do not use if printed bottle wrap is missing or broken
  • Inactive ingredients

    citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol, sucralose, water, xanthan gum

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    LIQUID
    BACTIMICINA®

    Diphenhydramine HCl / Antihistamine

    Children's
    Allergy

    Ages 6 & Over

    Relieves:

    • RUNNY NOSE
    • SNEEZING
    • ITCHY, WATERY EYES
    • ITCHY THROAT

    Alcohol Free

    Cherry Flavor

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BACTIMICINA CHILDRENS ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1565
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1565-41 in 1 CARTON06/17/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/17/2015
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1565) , LABEL(24286-1565)

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