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

  • NDC Code(s): 58593-002-06
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 20, 2024

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

  • ACTIVE INGREDIENT

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

    Brompheniramine Maleate 4mg ................................................ Antihistamine

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

  • PURPOSE

    Purpose

    Antihistamine

    Cough Suppressant

  • 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

    • glaucoma

    • high blood pressure

    • thyroid disease

    • diabetes

    • difficulty in urination due to an enlarged 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 and ask 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.
    • 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

    • 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=miliiter 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 teaspoonfuls) every 4 hours
    • children under 6 years of age
    • do not use

  • 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 from the common cold

  • INACTIVE INGREDIENT

    Inactive Ingredients:Blue Cohosh root extract, citric acid, Echinacea root extract, Eucalyptus Oil, Flavor, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, 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 9AM to 5PM EST

    www.efficientlabs.com


    Distributed by

    Efficient Laboratories, Inc., Miami, Fl 33166

    Made in U.S.A.

  • Ask a doctor or pharmacist before use if you are:

    taking tranquilizers or sedatives

  • When using this product


    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 childrens.

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO SF FLU  SF FLU
    brompheniramine maleate, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-002
    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 MALEATE4 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HONEY (UNII: Y9H1V576FH)  
    HOREHOUND (UNII: K08036XEJV)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LICORICE (UNII: 61ZBX54883)  
    MULLEIN LEAF (UNII: 9936O846LI)  
    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)  
    MYRRH (UNII: JC71GJ1F3L)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-002-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/01/2023
    Labeler - Efficient Laboratories Inc (969044932)
    Registrant - Efficient Laboratories Inc (969044932)