Label: ROMPE PECHO NT NT- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

  • NDC Code(s): 58593-003-06
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 8, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients:(in each 30ml doses cup) Purpose

    Acetaminophen 650mg ............................................................ Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg ..................................................Cough Suppressant

    Doxylamine succinate 12.5 mg ................................................ Antihistamine

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Cough Suppressant

    Antihistamine

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur f you take • more than 6 doses in 24 hours, which is the maximum daily amount for this prcx:luct • with other drugs containing acetaminophen • 3 or more alcoholic drinks daily wh le using this product.

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters• rash
    If a skin reaction occurs,stop use and seek medical help right away.


    Sore throat warning: If sore throat is severe,persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting,consult a doctor promptly.

  • DO NOT USE


    Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen,ask a doctor or phannacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions,or Parkinson'sdisease),or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI,ask a doctor or pharmacist before taking this product.
    • to make a childsleep_

  • 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.


    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well
    as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions do not take more than directed (see overdose warning)

    • 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
    • 30 mL every 4 hours
    • children under 12 years of age
    • do not use

  • INDICATIONS & USAGE

    Uses


    • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains• headache• sore throat• runny nose and sneezing • cough • relieves cough to help you get to sleep
    • temporarily reduces fever.

  • INACTIVE INGREDIENT


    Inactive ingredients: blue cohosh root extract, citric acid, echinacea root extract, eucalyptus oil, flavor, ginkgo biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, 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:


    Ask a doctor or pharmacist before use if you are
    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers.

  • When using this product



    When using this product • do not use more than directed
    • excitability may occur, especially in children• marked drowsiness may occur • avoid alcoholic
    drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a
    motor vehicle or operating machinery.

  • ASK DOCTOR


    Ask a doctor before use if you have:

    • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • trouble urinating due to enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis,or emphysema • a sodium-restricted diet.

  • STOP USE


    Stop use and ask a doctor if • nervousness, dizziness, or
    sleeplessness occur • pain or cough gets worse or lasts more than 7 days • new symptoms occur •fever gets worse or lasts more than 3 days • redness or swelling is present • cough comes back or occurs with rash or headache that lasts.
    These could be signs of a serious condition.

  • PRINCIPAL DISPLAY PANEL

    labelPack

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO NT  NT
    acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HONEY (UNII: Y9H1V576FH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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:58593-003-06180 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)