TUSSIN DM COUGH AND CHEST CONGESTION SUGAR-FREE READYINCASE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]

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  • TUSSIN DM COUGH AND CHEST CONGESTION SUGAR-FREE READYINCASE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]

TUSSIN DM COUGH AND CHEST CONGESTION SUGAR-FREE READYINCASE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0384-4
Set ID 4c5f480a-8751-462c-bf71-5f9c6887b9cd
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 10 mg

    Guaifenesin, 100 mg

  • Purposes

    Cough suppressant

    Expectorant

  • 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 bronchitis tubes
  • Warnings

    Do not use

    • 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • mL = milliliter
    • this adult product is not intended for use in children under 12 years of age
    • adult and children 12 years and over: 10 mL every 4 hours
    • children under 12 years : do not use
  • Other information

    • each 10 mL contains: potassium 5 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    acesulfame potassium, citric acid, flavors, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM*

    adult Tussin DM

    Sugar free

    Cough & chest congestion

    Dextromethorphan HBr

    Guaifenesin

    Relieves:

    • cough
    • chest congestion

    for ages 12 & over

    alcohol free

    non-drowsy

    specially formulated for diabetics

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    Manufactured by:

    PL Developments

    11865 S. Alameda St, Lynwood, CA 90262

  • Package Label

    Dextromethorphan HBr 10 mg, Guaifenesin 100 mg

    ReadyinCase Adult Tussin DM Suger-Free Cough & Chest Congestion

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM COUGH AND CHEST CONGESTION  SUGAR-FREE READYINCASE
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0384
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0384-41 in 1 BOX08/31/201412/30/2021
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/31/201412/30/2021
    Labeler - P & L Development, LLC (101896231)
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