Label: BACTIMICINA CHILDRENS COUGH AND COLD- chlorpheniramine maleate, dextromethorphan hydrobromide liquid

  • NDC Code(s): 24286-1551-4
  • 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 November 2, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 teaspoon)Purposes
    Chlorpheniramine maleate, USP 1 mgAntihistamine
    Dextromethorphan HBr, USP 7.5 mgCough suppressant
  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • sneezing
      • itching of the nose or throat
  • Warnings

    Do not use

    • to sedate a child or to make a child sleepy
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    • do not use more than directed 
    • marked drowsiness may occur 
    • avoid alcoholic drinks 
    • alcohol, sedatives, and tranquilizers may increase drowsiness 
    • be careful when driving a motor vehicle or operating machinery          
    • excitability may occur, especially in children

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    • do not take more than 4 doses in any 24-hour period
    • mL=mililiter; tsp=teaspoonful
    Age (years)Dose
    Under 6do not use
    6-112 teaspoons (10 mL) every 6 hours
    12 and over4 teaspoons (20 mL) every 6 hours
  • Other information

    • each teaspoon (5 mL) contains: sodium 1 mg
    • store at 15-30°C (59-86°F)
    • measure only with dosage cup provided
    • do not use if printed bottle wrap is missing or broken.
  • Inactive ingredients

    citric acid, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Long Acting TRUSTED SINCE 1978

    Children's

    Bactimicina

    Milti-Symptoms • Liquid Ages 6+ Years

    Cough & Cold

    Dextromethorphan HBr (Cough Suppressant)

    Chlorpheniramine Maleate (Antihistamine)

    Relieves Cough up to 8hrs • Sneezing • Runny Nose

    Alcohol Free

    Natural Strawberry Flavor

    4 FL OZ (118 mL) Bactimicina-Children

  • INGREDIENTS AND APPEARANCE
    BACTIMICINA CHILDRENS COUGH AND COLD 
    chlorpheniramine maleate, dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1551
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Colorred (Red) Score    
    ShapeSize
    FlavorSTRAWBERRY (Natural Strawberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1551-41 in 1 BOX10/23/2009
    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 finalpart34110/23/2009
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930manufacture(24286-1551) , label(24286-1551)
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