Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

  • NDC Code(s): 43598-114-01, 43598-114-20, 43598-114-40, 43598-115-28, view more
    43598-115-32, 43598-115-37, 43598-115-42, 43598-115-56, 43598-115-70, 43598-115-74
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 19, 2024

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  • Active ingredients

    (in each extended-release tablet)

    Guaifenesin USP, 600 mg

    Dextromethorphan Hydrobromide USP, 30 mg

    Guaifenesin USP, 1200 mg

    Dextromethorphan Hydrobromide USP, 60 mg

  • Purposes

    Expectorant

    Cough suppressant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep

  • Warnings

    Do not use

    • for children under 12 years of age
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    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 use more than directed

    Stop use and ask a doctor if

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

    These could be signs of a serious illness.

    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 (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 timing of meals
    • children under 12 years of age: do not use

    For 600 mg/30 mg:

    • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

    For 1200 mg/60 mg:

    • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.
  • Other information

    • store at 20°C to 25°C (68°F to 77°F)

  • Inactive ingredients

    carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

  • Questions

    call 1-888-375-3784 Weekdays (9am - 8pm EST)

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Dr. Reddy’s Laboratories, Inc.

    Princeton, NJ 08540

    Made in India

    Issued: 10/2022

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin 600 mg and Dextromethorphan 30 mg Extended-Release Tablets

    Carton:

    carton1

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets

    Carton:

    carton2

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HBR 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-114
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-114-201 in 1 CARTON08/15/2023
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:43598-114-402 in 1 CARTON08/15/2023
    220 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:43598-114-015 in 1 CARTON08/15/2023
    320 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21734008/15/2023
    GUAIFENESIN AND DEXTROMETHORPHAN HBR 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code 6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-115-701 in 1 CARTON08/15/2023
    17 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:43598-115-322 in 1 CARTON08/15/2023
    27 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:43598-115-284 in 1 CARTON08/15/2023
    37 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:43598-115-426 in 1 CARTON08/15/2023
    47 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:43598-115-373 in 1 CARTON08/15/2023
    5NDC:43598-115-7414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:43598-115-564 in 1 CARTON05/30/2024
    6NDC:43598-115-7414 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21734008/15/2023
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Reddy's Laboratories Limited- FTO3918608162manufacture(43598-114, 43598-115) , analysis(43598-114, 43598-115)
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