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 68016-018-04
Set ID 085ad4a1-5d3d-46e2-ad6b-6b5b94e0d3f6
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
  • Other information

    • Keep carton for full Directions for use.
    • store at 20‐25 ° C (68‐77 ° F)
    • do not refrigerate
    • dosage cup provided
    • sodium 3 mg per teaspoonful
  • 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 68016-018-04

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


    Premier Value®

    Tussin DM

    Dextromethorphan HBr
    Guaifenesin

    COUGH SUPPRESSANT /
    EXPECTORANT

    Helps to Loosen
    Chest Congestion

    NON-DROWSY

    Cough Formula
    for ages 12 and over


    4 FL OZ (118 mL)

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refundd.
    *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

    BX-003

    AptaPharmaPV TussinDM3 Label

    res

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  COUGH SUPPRESSANT/EXPECTORANT
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-018
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-018-04118 mL in 1 BOTTLE, PLASTIC; 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(68016-018)

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