TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [APTAPHARMA INC.]

TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [APTAPHARMA INC.]
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NDC 76281-310-26
Set ID 7eead561-ee36-4d85-936b-f472c56a75c6
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)

    Dextromethorphan HBr, USP     20 mg

    Guaifenesin, USP                      200 mg

  • 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 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 DOCTOR

    Ask a doctor before use if you have • cough that occurs with
    too much phlegm (mucus) • cough that lasts or is 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 a health 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
    • mL = milliliter

    AgeDose
     Adults & children 12 years & over 10 mL every 4 hours
     Children under 12 years Do not use

  • OTHER SAFETY INFORMATION

    Other information
    • store at 20-25oC (68-77oF)
    • do not refrigerate
    • dosage cup provided
    each 10 mL contains: sodium 3 mg

  • INACTIVE INGREDIENT

    Inactive ingredients

    Anhydrous citric acid, flavor, purified water,
    sodium benzoate, sucrose

  • QUESTIONS

    Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Principal Display Panel

    CVS
    HealthTM

    Compare to the active
    ingredients in Robitussin® Peak
    Cold Cough & Chest Congestion*

    MAXIMUM STRENGTH

    Non-Drowsy
    Tussin DM
    ADULT COUGH &
    CHEST CONGESTION

    Free of alcohol, dyes &
    artificial sweeteners

    DEXTROMETHORPHAN HBr
    Cough suppressant

    GUAIFENESIN
    Expectorant

    Relieves:
    • Cough
    • Chest Congestion

    For Ages
    12 & Over

    Cherry Flavor

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

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

    Lot:
    Exp:

    LR-108 REV 01 #339107

    0 50428 61311 5

    CONTINUED
    ON BACK

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2018 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-34690

    √CVS Quality
    Money Back Guarantee

    ↓Product Package↓

    310-26 Label

                                   Tussin DM by CVS Pharmacy, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-310-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-310)

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