ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]

ROMPE PECHO EX (GUAIFENESIN) LIQUID [EFFICIENT LABORATORIES INC]
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NDC 58593-829-06
Set ID 89ea23a5-0da7-407e-83d9-77a0b562f3af
Category HUMAN OTC DRUG LABEL
Packager Efficient Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

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

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

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    Ask a doctor before use if you have

    •  a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
  • DO NOT USE

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • 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

    Age                                                       Dose

    adults and children 12 years and over       10 mL (2tsps) every 4 hrs.

    children 6 to under 12 years of age            5 mL (1 tsp) every 4 hrs

    children under 6 years of age                consult a doctor

  • 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

  • PRINCIPAL DISPLAY PANEL

    rompepechoRegLabel

    image description

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO  EX
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-829
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 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)  
    ASCLEPIAS TUBEROSA ROOT (UNII: 1ZL82U5D18)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-829-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    2NDC:58593-829-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2015
    Labeler - Efficient Laboratories Inc (969044932)

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