Label: MMM GUAIFENESIN SOLUTION- guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 13, 2021

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

  • ACTIVE INGREDIENT

    Each 5 mL (1 tespoonful) contains:

    Guaifenesin USP 100mg

  • PURPOSE

    Expectorant
    SUGAR FREE / ALCOHOL

  • DO NOT USE

    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.

  • WARNINGS

    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.

    Stop use and ask a doctor if

    cough persists for more than1 week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

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


    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

    Center right away.

  • INDICATIONS & USAGE

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • STOP USE

    Stop use and ask a doctor if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.

  • DOSAGE & ADMINISTRATION

    Do not take more than 6 doses in any 24 hours period

    Adults and children 12 years and over - 10 to 20ml (2 to 4 teaspoonfuls every 4 hours or as directed by doctor)

    children under 12 years - do not use

  • STORAGE AND HANDLING

    Store at room temperature 15º-30ºC (59º-86ºF)

    Tamper-Evident: Do not use if seal under cap is torn, broken or missing.

  • INACTIVE INGREDIENT

    Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potasium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD &C Red # 40 ,caramel color,purified water.

  • 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.

  • MMM - guaifenesin solution

    MMM Expectorant

  • INGREDIENTS AND APPEARANCE
    MMM GUAIFENESIN SOLUTION 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-020
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-020-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2021
    Labeler - Southern Sales & Services, Inc. (013114906)
    Registrant - Southern Sales & Services, Inc. (013114906)