Label: ROMPE PECHO CF- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 58593-235-04, 58593-235-06, 58593-235-08, 58593-235-10, view more
    58593-235-29
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL

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 December 29, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

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

    Dextromethorphan HBr 10 mg ...................................... Cough Suppressant

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

    Phenylephrine HCL  5 mg .................................................... Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    Do not use

    • If you are 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 your doctor or pharmacist before taking this product.

  • DO NOT USE



    Ask a doctor before use if you have
    • heart disease

    • high blood pressure

    • thyroid disease

    • diabetes

    • trouble urinating due to an enlarged prostate gland

    • a persistant or chronic cough

    • a cough that is accompanied by excessive phlegm (mucus)

    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema.


    Stop use and ask doctor if

    • symptoms do not improve within 7 days or is accompanied by a fever, rash, or persistent headache. A persistent cough may be sign of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
  • 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 consult a doctor 

  • INDICATIONS & USAGE

    Uses

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein leaf extract, Myrrh gum extract, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, 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


    Distributed by

    Efficient Laboratories, Inc., Miami, Fl 33166

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

    rompepechocf

    RPCFBogo

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO  CF
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-235
    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
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    HOREHOUND (UNII: K08036XEJV)  
    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)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-235-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2007
    2NDC:58593-235-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    3NDC:58593-235-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    4NDC:58593-235-29296 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package01/01/2015
    5NDC:58593-235-1010 mL in 1 POUCH; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2007
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)