Label: NIGHTTIME COUGH ALL NIGHT COUGH RELIEF- dextromethorphan hydrobromide, doxylamine succinate liquid

  • NDC Code(s): 49580-0345-1, 49580-0345-2, 49580-0345-4, 49580-0345-6
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 24, 2023

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  • Active ingredients (in each 30 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purposes

    Cough suppressant

    Antihistamine

  • Uses

    • temporarily relieves cold symptoms
    • cough due to minor throat and bronchial irritation
    • runny nose and sneezing
  • 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

    • glaucoma
    • a breathing problem or chronic cough thats lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedative or tranquilizers.

    When using this product

    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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 breast-feeding,

    ask a health professiuonal before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

  • Directions

    • keep dosing cup with product
    • do not take more than 4 doses in any 24-hour period
    • take only as directed
    • measure only with dosing cup provided. Do not use any other dosing device.
    • mL = milliliter
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: do not use
  • Other information

    • each 30 mL contains; sodium 29 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    alcohol, citric acid, FD&C blue 1, FD&C red 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

  • Principal Display Panel

    Compare to active ingredients in Vicks® NyQuil® Cough*

    Night Time

    Cough

    all night cough relief

    Dextromethorphan HBr

    Doxylamine succinate

    Relieves:

    • cough
    • runny nose
    • sneezing

    for ages 12 and over

    nighttime relief

    alcohol 10%

    FL OZ (mL)

    cherry flavor

    *This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

    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

  • Product Label

    Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

    READYINCASE Nighttime Cough Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH  ALL NIGHT COUGH RELIEF
    dextromethorphan hydrobromide, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0345
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0345-1296 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
    2NDC:49580-0345-6177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
    3NDC:49580-0345-2355 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
    4NDC:49580-0345-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/201412/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/201412/31/2024
    Labeler - P & L Development, LLC (101896231)
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