BACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]

BACTIMICINA CHILDRENS COUGH AND COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [DLC LABORATORIES, INC.]
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NDC 24286-1551-4
Set ID d407a583-07ae-4d47-b15a-24b5865c82da
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

    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
    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)
    • 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

    LIQUID
    BACTIMICINA
    ®

    Chlorpheniramine Maleate / Antihistamine
    Dextromethorphan HBr / Cough Suppressant

    Children's
    Cough
    & Cold

    Ages 6 & Over

    Relieves:
    • COUGH: up to 8 hours
    • SNEEZING
    • RUNNY NOSE
    • ITCHY, WATERY EYES

    Alcohol Free
    Long-Acting

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • 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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