ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]

ROMPE PECHO DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]
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NDC 58593-275-04, 58593-275-06, 58593-275-08, 58593-275-10
Set ID d108c712-bc36-41d7-9ccd-720496b5599e
Category HUMAN OTC DRUG LABEL
Packager Efficient Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients:(in each teaspoonful 5 ml.)                                Purpose

    Dextromethorphan Hydrobromide 10 mg ...................................... Cough Suppressant

    Guaifenesin 100 mg ................................................................... Expectorant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses:

    • temporarily relieves cough as may occur with the common cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus.
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    • a cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
  • DO NOT USE

    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 on MAOI, ask a doctor or pharmacist before taking this product.  

    • Stop use and ask a doctor
    • If cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • PREGNANCY OR BREAST FEEDING

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


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Shake well before use

    Do not exceed more than 6 doses in any 24 hour period or as directed by a doctor

    Age                                                                             Dose

    Adults and Children 12 years of age and over              10 mL (2 tsps.) every 4 hours

    Children 6 to under 12 years of age                            5 mL (1 tsp.) every 4 hours

    Children under 6 years of age                                     Do not use

  • INACTIVE INGREDIENT

    Inactive Ingredients: Blue Cohosh root extract, Echinacea root extract, Eucalyptus oil, Gingka Biloba leaf extract, glycerin, Golden Seal Root extract, Honey, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Pleurisy Root, Potassium sorbate, polysorbate 80, propolis extract, propylene glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Spearmint flavor, Sucralose, water, Wild Cherry Bark extract and Zinc Sulfate.

  • QUESTIONS

    Questions or Comments?

    305-805-3456 Monday - Friday 9AM to 5PM EST

    www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    rompepechoDMLabel

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO  DM
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-275
    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
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    GINKGO (UNII: 19FUJ2C58T)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HONEY (UNII: Y9H1V576FH)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)  
    MYRRH (UNII: JC71GJ1F3L)  
    ASCLEPIAS TUBEROSA ROOT (UNII: 1ZL82U5D18)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-275-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2001
    2NDC:58593-275-1010 mL in 1 POUCH; Type 0: Not a Combination Product10/01/2001
    3NDC:58593-275-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    4NDC:58593-275-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2001
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)

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