Label: COUGH OUT- guaifenesin liquid

  • NDC Code(s): 58593-255-04, 58593-255-06
  • Packager: Efficient Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2025

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

  • ACTIVE INGREDIENT

    Active Ingredient: (In each teaspoonful 5 mls)         Purpose

    Guiafenesin 100 mg (USP)............................................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 cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    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 persstent headached. A persistent cough may be a sign of a 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 immediately before use.

    Do not exceed 6 doses in any 24 hour period. 

    Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours

    Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours

    Children under 6 years of age - Do not use

  • INACTIVE INGREDIENT

    Inactive Ingredients:Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water

  • OTHER SAFETY INFORMATION

    Each 5 mls contains: sodium 5 mg, and potassium 5 mg

    Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful). 

  • QUESTIONS

    Questions or Comments?

    305.805.3456 Monday-Friday 9AM to 5PM EST

    www.efficientlabs.com


  • PRINCIPAL DISPLAY PANEL

    CoughOutLabel

  • INGREDIENTS AND APPEARANCE
    COUGH OUT 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-255
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HONEY (UNII: Y9H1V576FH)  
    MENTHOL (UNII: L7T10EIP3A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-255-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199705/16/2023
    2NDC:58593-255-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199710/31/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/199710/31/2026
    Labeler - Efficient Laboratories Inc. (969044932)
    Registrant - Efficient Laboratories Inc. (969044932)