Label: ROMPE PECHO EX- guaifenesin liquid

  • NDC Code(s): 58593-829-04, 58593-829-06
  • Packager: Efficient Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2024

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

  • ACTIVE INGREDIENT

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

    Guaifenesin 200 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

    • do not exceed more than 6 doses in any 24 hour period
    • mL=milliliter
    • this adult product is not intended for use in children under 12 years
    AgeDose
    adults and children 12 years and over10 mL (2 teaspoonful) every 4 hours
    children under 12 years of agedo not use
  • OTHER SAFETY INFORMATION

    Other information

    • each 10 mL contains: potassium 5 mg
    • store between 15° - 30°C (59° - 86°F). Do not refrigerate
    • product color & flavor may vary due to natural honey

    TAMPER - EVIDENT FEATURE: Do not use this product if printed safety seal over cap is torn, broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Blue Cohosh root extract, Echinacea root extract, Eucalyptus Oil, 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 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) or www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    labelbox

  • 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) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    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 DrugM01201/01/2015
    Labeler - Efficient Laboratories Inc (969044932)