TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]

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  • TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]

TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]
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NDC 57243-503-24
Set ID e25727d0-7dd7-4ef5-b064-7938679f075f
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug FactsActive 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 You 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

    Age                                       Dose

    adults & children                     2 teaspoonfuls
    12 years and over                  every 4 hours

    children under 12 years           do not use

  • Other information

    • store at 20-25° C (66-77° F)
    • do not refrigerate
    • dosage cup provided
    • sodium 3 mg per teaspoon
  • Inactive ingredients

    Anhydrous citric acid, dextrose, FD & C red # 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

  • Tussin Cough DM product label

    * COMPARE TO ROBITUSSIN® PEAK COLD ACTIVE INGREDIENTS


    CVP® CONSUMER VALUE PRODUCTS

    TUSSIN COUGH EXPECTORANT COUGH SUPPRESSANT DM

    NON-DROWSY COUGH FORMULA

    • ADULT
    • FOR AGES 12 AND OVER
    • CONTROLS COUGH
    • HELPS LOOSEN CHEST CONGESTION

    4 FL OZ (118 Ml)

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

    Box-001 Rev 01

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Distributed by: Salado Sales, Inc.  P.O. Box 6115 Temple, TX 76503  www.saladosales.com

    LOT.

    EXP.

    AptaSS TussinDM 503

    AptaSS TussinDM 503 1

  • INGREDIENTS AND APPEARANCE
    TUSSIN COUGH  EXPECTORANT COUGH SUPRESSANT DM
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-503
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-503-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2012
    Labeler - Salado Sales, Inc. (009830555)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(57243-503)
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