TUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]

TUSSIN LONG ACTING COUGH READYINCASE (DEXTROMETHORPHAN HBR) LIQUID [P & L DEVELOPMENT, LLC]
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NDC 49580-0383-4
Set ID ac21ec89-12a3-4c83-9557-98a964e5d8de
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active ingredient (in each 10 mL)

    Dextromethorphan HBr, 30 mg

  • Purpose

    Cough suppressant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • 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 4 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 6 to 8 hours
    • children under 12 years: do not use
  • Other information

    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, dextrose, ethyl alcohol, FD&C red 40, flavor,  glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Questions or comments?

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

  • Principal Display Panel

    Compare to active ingredient in Robitussin® Lingering Cold Long-Acting Cough*

    Tussin

    Long-acting

    Cough

    Dextromethorphan HBr, 30 mg

    cough suppressant

    Relieves cough for up to 8 hours

    For ages 12 & over

    alcohol 1.4%

    non-drowsy

    Dosing Cup Included

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Lingering Cold Long-Acting Cough.

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

    Manufactured by:

    PL Developments

    11865 S. Alamea St

    Lynwood, CA 90262

  • Package Label

    Dextromethorphan HBr 30 mg

    READYINCASE Tussin long-acting cough

  • INGREDIENTS AND APPEARANCE
    TUSSIN LONG ACTING COUGH  READYINCASE
    dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0383
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALCOHOL (UNII: 3K9958V90M)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0383-41 in 1 BOX08/31/201412/30/2022
    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 FINALpart34108/31/201412/30/2022
    Labeler - P & L Development, LLC (101896231)

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