TUSSIN DM COUGH SUPPRESSANT/EXPECTORANT (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]

TUSSIN DM COUGH SUPPRESSANT/EXPECTORANT (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-855-56, 68016-855-57
Set ID fb17566a-65d7-4df5-b0ea-469edf6e38df
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredients

    Drug Facts

    Active ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg

  • Purpose

    Cough Suppressant
    Expectorant

  • 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.

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • 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 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 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.

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    AptaPharmaPV TussinDM2 Label
  • Other information

    • store at 20‐25 ° C (68‐77 ° F)
    • do not refrigerate
    • dosage cup provided
    • sodium 3 mg per teaspoonful
    • See carton for full labeling
  • Inactive ingredients

    anhydrous citric acid, dextrose, FD and C red no.40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions?

    Call weekdays from 9:30 AM to 4:30 PM EST at

    1-877-798-5944

  • Product Label

    NDC 68016-855-56

    *COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD COUGH and CHEST CONGESTION DM

    Premier Value®
    Tussin DM

    Dextromethorphan HBr
    Guaifenesin

    COUGH SUPPRESSANT /
    EXPECTORANT

    NON-DROWSY

    Helps to Loosen
    Chest Congestion

    Cough Formula
    for ages 12 and over


    8 FL OZ (237 mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED
    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

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

    DISTRIBUTED BY:
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431

    LR-018

    LOT:     EXP:

    AptaPharmapv TussinDM Label

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  COUGH SUPPRESSANT/EXPECTORANT
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-855
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-855-56237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2012
    2NDC:68016-855-57354 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-855)

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