Label: ROMPE PECHO SF- guaifenesin liquid

  • NDC Code(s): 58593-265-04, 58593-265-06
  • Packager: Efficient Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 3, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT


    Active Ingredient (In each 5ml teaspoonful)................. Purpose


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

  • PURPOSE


    Purpose

    Expectorant

  • INDICATIONS & USAGE


    Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to rid the 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 accompainied by a fever, rash or persistent headache. A persistent cough may be a sign of serious condition.

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.
    In case of accidental overdose, get medical help or contact the Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:Shake well before use. Do not exceed 6 doses in any 24 hour period or as directed by a doctor

     AgeDose
    adults and children 12 years of age and over 10 mL (2tsps) every 4 hours
    children 6 to under 12 years of age 5 mL (1 tsp) every 4 hours 
    children under 6 years of age consult a doctor 

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, 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-5PM EST

    www.efficientlabs.com

  • PRINCIPAL DISPLAY PANEL

    rompepechosflabel

  • INGREDIENTS AND APPEARANCE
    ROMPE PECHO   SF
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-265
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HOREHOUND (UNII: K08036XEJV)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)  
    MYRRH (UNII: JC71GJ1F3L)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (Honey Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-265-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    2NDC:58593-265-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/1999
    Labeler - Efficient Laboratories, Inc. (969044932)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmalab Enterprises, Inc.174401088manufacture(58593-265)