Label: GILTUSS HBP EX EXPECTORANT tablet

  • NDC Code(s): 58552-340-07, 58552-340-20
  • Packager: Gil Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2025

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

  • Drug Facts

  • Active ingredient Purpose (in each extended-release bi-layer tablet)

    Guaifenesin, 600 mg....................................................................Expectorant

  • PURPOSE

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.
  • Warnings

    • Do not use for children under 12 years
  • Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)
  • Stop use and ask a doctor if

    Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness.

  • 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 accidental overdose, get medical or professional help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours
    • do not exceed 4 tablets in 24 hours
    • children under 12 years of age: do not use
  • Other information

    • Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing
    • Store between 20°-25°C (68°-77°F)
    • SAVE CARTON FOR COMPLETE DRUG FACTS
  • INACTIVE INGREDIENT

    Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch  glycolate.

  • Questions or comments?

    Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.

    revised: 08/25

  • PRINCIPAL DISPLAY PANEL

    GILTUSS HBP EX EXPECTORANT / EXPECTORANTE (Guaifenesin 600 mg) - NDC 58552-340-20 - 20 Tabs Bottle label

    image description

  • INGREDIENTS AND APPEARANCE
    GILTUSS HBP EX EXPECTORANT 
    giltuss hbp ex expectorant tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-340
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58552-340-201 in 1 CARTON10/07/2025
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58552-340-071 in 1 CARTON10/07/2025
    27 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/07/2025
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neeyaan, LLC118819217manufacture(58552-340)