Label: BACTIMICINA CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

  • NDC Code(s): 24286-1565-4
  • Packager: DLC Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 July 5, 2023

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  • 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

    4-6 Hour Relief

    Voltee Para

    Español

    TRUSTED SINCE 1978

    New

    Look

    Children's

    Bactimicina®

    Ages 6+ Years

    Antihistamine • Liquid

    Allergy

    Diphenhydramine HCL (Antihistamine)

    Sneezing • Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Alcohol Free

    Cherry Flavor

    4 FL OZ (118 mL) Dosing Cup Included Bactimicina Children's Allergy

  • 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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