TUSSIN COUGH AND CHEST CONGESTION DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]

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TUSSIN COUGH AND CHEST CONGESTION DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0386-4
Set ID 456a4914-eb8d-440b-8446-744205811905
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 20 mg

    Guaifenesin  400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial 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, 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
    • adults and children 12 years and over: 10 mL every 4 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    carboxymethylcellulose sodium, anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, xanthan gum

  • Questions or comments?

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

  • Principal Display Panel

    Compare to active ingredients in Robitussin® Peak Cold Maximum Strength Cough & Chest Congestion DM*

    maximum strength

    tussin dm

    cough & chest congestion

    dextromethorphan HBr

    guaifenesin

    relieves:

    • cough
    • chest congestion

    For ages 12 & over 

    alcohol-free

    non-drowsy

    FL OZ (mL)

    Dosing Cup Included

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Robitussin® Peak Cold Maximum strength Cough+Chest Congestion DM. 

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Manufacture by:

    PL Developments

    11865 S. Alameda St

    Lynwood, CA 90262

  • Package Label

    Dextromethorphan HBr 20 mg, Guaifenesin 400 mg

    READYinCASE Maximum strength Tussin DM Cough & Chest Congestion

  • INGREDIENTS AND APPEARANCE
    TUSSIN COUGH AND CHEST CONGESTION DM  MAXIMUM STRENGTH
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0386
    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) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0386-41 in 1 BOX03/31/201612/30/2023
    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 finalpart34103/31/201612/30/2023
    Labeler - P & L Development, LLC (101896231)
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