Label: GUAIFENESIN 200MG- guaifenesin tablet

  • NDC Code(s): 71679-148-02, 71679-148-30
  • Packager: Health Pharma USA LLC
  • 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.

View All Sections
  • Active ingredient (in each tablet)

    Guaifenesin 200 mg

  • Purpose

    Expectorant

  • Uses

    • Temporary symptomatic relief from congested chests and cough.
  • Warnings

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

    Ask a doctor before use if you have

    • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
    • Cough accompanied by too much phlegm (mucus).

    When using this product

    • Do not exceed recommended dosage.
    • Do not consume alcohol, benzodiazepines or opioids. 

    Stop use and ask a doctor if

    cough lasts for more than 7 days please consult your physician or healthcare provider.

    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 (1-800-222-1222) right away.

  • Directions

    • Adults and children 12 years of age and over:take 1 tablet a day. 
    • children under 12 years:do not use.
    • Do not exceed 4 doses in 24 hours.
  • Other Information

    • Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
    • Keep in a dry place and do not expose to heat.
    • Read all product information before use.
    • TEMPERR EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

  • PRINCIPAL DISPLAY PANEL-30 Count

    label

  • PRINCIPAL DISPLAY PANEL-200 Count

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 200MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-148-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    2NDC:71679-148-02200 in 1 BOTTLE; Type 0: Not a Combination Product06/18/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/18/2025
    Labeler - Health Pharma USA LLC (080804485)
    Registrant - Health Pharma USA LLC (080804485)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(71679-148)
    Establishment
    NameAddressID/FEIBusiness Operations
    HHH PHARMA USA LLC062788820pack(71679-148)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!