BACTIMICINA COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [DLC LABORATORIES, INC.]

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  • BACTIMICINA COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [DLC LABORATORIES, INC.]

BACTIMICINA COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [DLC LABORATORIES, INC.]
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NDC 24286-1546-4
Set ID 2e612c62-9bbb-45f2-a253-aa2bfaeaac70
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 teaspoon)Purposes
    Dextromethorphan HBr, USP 10 mgCough Suppressant
    Guaifenesin, USP 100 mgExpectorant
    Phenylephrine HCl, USP 5 mgNasal Decongestant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves these symptoms occurring with a cold:
      • nasal congestion
      • cough due to minor throat and bronchial irritation
  • Warnings

    Do not use

    • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

    When using this product do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • 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 6 doses in any 24-hour period
    • this adult product is not intended for children under 12 years old
    Age (years)Dose
    12 and over2 teaspoons (10 mL) every 4 hours
    Under 12do not use
  • Other information

    • each teaspoon (5 mL) contains: sodium 2 mg
    • store at 15-30°C (59-86°F)
    • dosage cup provided
  • Inactive ingredients

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

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box

    LIQUID
    BACTIMICINA®

    Dextromethorphan HBr / Cough Suppressant
    Guaifenesin / Expectorant
    Phenylephrine HCl / Nasal Decongestant

    Cough
    & Cold

    Relieves:

    • COUGHS
    • STUFFY NOSE
    • CHEST CONGESTION

    For Ages 12 & Over

    Non-Drowsy Formula
    Alcohol Free

    Strawberry Flavor

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    BACTIMICINA COUGH AND COLD 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1546
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1546-41 in 1 BOX11/06/2013
    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 FINALpart34111/06/2013
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1546) , LABEL(24286-1546)
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