ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]

ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]
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NDC 58593-828-08
Set ID 938e4e47-d2d9-4b0d-bf88-e9f41b501945
Category HUMAN OTC DRUG LABEL
Packager EFFICIENT LABORATORIES INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients                                            Purposes

    (in each 20mL)

    Acetaminophen 650 mg..................................Pain reliever/feverreducer

    Dextromethorphan Hbr 20 mg............................Cough suppressant

    Guaifenesin 400 mg...........................................Expectorant

    Phenylephtine HCl 10 mg...................................Nasal decongestant

  • PURPOSE

    • Pain reliever/fever reducer
    • Cough suppressant
    • Expectorant
    • Nasal decongestant
  • INDICATIONS & USAGE

    Uses

    • temprarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure 
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • WARNINGS

    Warning

    Do not exceed recommended dosage.

    • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlgem(mucus) unless directed by a doctor.

    Liver warning: this product contains acetaminophen. Severe liver damage may occur if

    • you take more than 6 doses in 24 hours, which is the maximum daily amount for this product
    • taken with other drugs containing acetaminophen
    • 3 or more alcoholic drinkss every day while using this product

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

  • 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 a pharmacist.
    • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • 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 pharmamcist before taking this product.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have

    • heart disease
    • liver disease
    • 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, chronic bronchitis or emphysema.
    • a cough that is followed by excessive phlegm (mucus)

    Ask a docotor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking tranquilizers or sedatives
  • STOP USE

    Stop use and ask a doctor if

    • a symptoms do not improve within 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
    • nervousness, dizziness or sleeplessness occurs
    • pain and nasal congestion gets worse or last more than 5 days (children) or 7 days (adults)
    • fever gets worse or last more than 3 days
    • redness or swelling  is present  or new symptoms occur.
  • 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

    • shake well before use 
    • do not exceed more than 6 doses in any 24 hour period or as directed by a doctor
    • adults and children 2 years of age and over: 20 mL (4 teaspoonful) every 4 hours
    • children under 12 years of age: consult a docotr
  • INACTIVE INGREDIENT

    Inactive ingreadients:

    Blue cohosh, citirc acid, echinacea, eucalptus oil, ginko biloba, glycerin, golden seal root, honey, horehound herb, licorice root, menthol, methylparaben, mullein leaves, myrrh, potassium citrate, potassium sorbate, propylene  glycol, propylparaben, slippery elm bark, sodium chloride, suralose, water, wild cherry bark, zinc sulfate

  • QUESTIONS

    Questions or comments?

    Call (305) 805-3456

    Monday-Friday 9 am- 5 pm EST or www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    rpmax label

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO MAX MULTI SYMPTOMS 
    acetaminophen, dextromethophan hbr, phenylephrine hcl, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-828
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HONEY (UNII: Y9H1V576FH)  
    HOREHOUND (UNII: K08036XEJV)  
    LICORICE (UNII: 61ZBX54883)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MULLEIN LEAF (UNII: 9936O846LI)  
    MYRRH (UNII: JC71GJ1F3L)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-828-081 in 1 CARTON01/01/2014
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2014
    Labeler - EFFICIENT LABORATORIES INC (969044932)