Label: TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM- dextromethorphan hydrobromide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients (in each 5mL tsp)
    Dextromethorphan HBr, USP 10mg 
    Guaifenesin, USP 100mg

  • PURPOSE

    Purpose
    Dextromethorphan HBr, USP .... Cough Suppressant
    Guaifenesin, USP .............................. Expectorant

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves cough due to minor throat and
       bronchial irritation as may occur with acold
    ■ helps loosen phlegm (mucus) and thin bronchial
       secretions to drain bronchial tubes

  • WARNINGS

    Warnings
    Do not use ■ in a child under 12 years of age
    ■ if you are now taking aprescription monoamine
    oxidase inhibitor (MAOI) (certain drugs for
    depression, psychiatric or emotional conditions, or
    Parkinson's disease) or for 2 weeks atter stopping
    the MAOI drug. If you do not know if your
    prescription drug contains a MAOI, ask adoctor or
    pharmacist before using this product.

  • ASK DOCTOR

    Ask a doctor before use if you have
    ■ cough that occurs with too much phlegm (mucus)
    ■ cough that lasts or chronic, such as occurs with
    smoking, asthma, chronic bronchitis or emphysema

  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7
    days, comes back or is accompanied by fever. rash or
    persistent headache. These could be signs of a
    serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ do not take more than 6 doses in any 24-hour period.

    ------------------------------------------------------------------------

     Age                                       Dose
    ------------------------------------------------------------------------
    Adults and children                 2 teaspoonfuls
    12 years and over                    every 4 hours
    ------------------------------------------------------------------------
    children under 12 years          do not use
    _________________________________________

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at 20-25°C (68-77°F) ■ do not refrigerate
    ■ dosage cup provided ■ sodium 3 mg per
       teaspoonful
     Keep carton for full directions for use.

  • INACTIVE INGREDIENT

    Inactive ingredientsAnhydrous citric acid,
    dextrose, FD&C red #40, flavor, glycerin, high
    fructose corn syrup, menthol, purified water.
    saccharin sodium, sodium benzoate.

  • Package Label

    AP SAFE  NDC 76281-503-24

    COMPARE TO THE ACTIVE
    INGREDIENTS IN ROBlTUSSIN®
    PEAK COLD COUGH & CHEST
    CONGESTION DM*

    Adult
    Tussin
    Cough

    Dextromethorphan HBr / Guaifenesin

    Cough Suppressant / Expectorant

    Non-Drowsy
    Cough Formula

    • Controls Cough
    • Helps Loosen chest
       congestion
    • For Ages 12 and over

    DM

    4 FL OZ (118 mL)

    CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER
    CAP IS BROKEN OR MISSING.

    3
    1013430
    3/20

    'This product is not manufactured or distributed
    by Pfizer, owner of the registered trademark
    Robitussin® Peak Cold.

    Manufactured by:
    AptaPharma Inc.,
    1533 Union Ave.
    Pennsauken, NJ 08110

    AP-BX-02

    Carton

    503-24 Box503-24 Box

    Bottle

    503-24 Btl503-24 Btl

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN COUGH  EXPECTORANT COUGH SUPRESSANT DM
    dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-503
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-503-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/30/2020
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-503)