Label: ROMPE PECHO SF FLU- dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid

  • NDC Code(s): 58593-225-06
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT


    Active ingredients(in each 5 mls tsp.)                          Purpose

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

    Brompheniramine Maleate 4 mg ................................. Antihistaminic

    Phenylephrine HCl 10 mg ................................. Nasal Decongestant

  • PURPOSE


    Purpose

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • INDICATIONS & USAGE

    USES

    • temporarily relieves runny nose, sneezing, itching of the nose or throat and itchy watery eyes due to hay fever or other upper respiratory allergies
    • temporarily relieves cough and nasal congestion as may occur with the common cold
  • WARNINGS

    Warnings

    Do not exceed recommended dosage

    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 DOCTOR

    Ask a doctor before use if you have • heart disease • glaucoma • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • a persistent or chronic cough such as occurs with smoking, asthma or emphysema • a cough that is accompanied by excessive phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis.

  • STOP USE

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days, cough tends to recur, or symptoms are accompanied by a fever, rash or persistent headache. A persistent cough may be sign of a serious condition
    • if nervousness, dizziness, or sleeplessness occur.
  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product • may cause marked drowsiness • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness effect • use caution when driving a motor vehicle or operating machinery • excitability may occur, especially in children.

  • 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 overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • do not exceed more than 6 doses in any 24-hour period
    • shake well before use
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter
    • TSP = teaspoonful
    • this adult product is not intended for use in children under 12 years of age

    Age Dose
    adults and children 12 years of age and over 5 mL (1 teaspoonful) every 4 hours
    children under 12 years of age do not use

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, flavor, Ginkgo Biloba leaf extract, Glycerin, Goldenseal Root extract, Horehound (flower, leaf, stem) extract, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, 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 (9 AM to 5 PM EST) or www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO  SF FLU
    dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-225
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    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 CITRATE (UNII: EE90ONI6FF)  
    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)  
    HOREHOUND (UNII: K08036XEJV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-225-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2007
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)