NIGHTTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.]

NIGHTTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [APTAPHARMA INC.]
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NDC 76281-308-26
Set ID a10c4c14-d4e9-4e5f-bd07-3c5597c051be
Category HUMAN OTC DRUG LABEL
Packager AptaPharma Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL)
    Dextromethorphan HBr              30 mg
    Doxylamine Succinate            12.5 mg

  • PURPOSE

    Purpose
    Dextromethorphan HBr ..................... Cough suppressant
    Doxylamine Succinate ...................... Antihistamine

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves cold symptoms:
    • runny nose and sneezing
    • cough

  • WARNINGS

    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. • to make a child sleepy

  • ASK DOCTOR

    Ask a doctor before use if you have • a sodium restricted diet
    • glaucoma • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with
    smoking, asthma, chronic bronchitis, or emphysema • trouble
    urinating due to an enlarged prostate gland

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use • if you are taking
    sedatives or tranquilizers

  • WHEN USING

    When using this product • do not use more than directed
    • avoid alcoholic drinks • excitability may occur, especially in
    children • marked drowsiness may occur • be careful when driving
    amotor vehicle or operating machinery • alcohol, sedatives, and
    tranquilizers may increase drowsiness

  • STOP USE

    Stop use and ask a doctor if • redness or swelling is
    present • cough lasts more than 7 days, comes back, or
    occurs with fever, rash, or headache that lasts. These
    could be signs of aserious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional
    before use.

  • Keep out of reach of children

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions
    • use dose cup
    • do not exceed 4 doses per 24 hours
    • When using Day Time and Night Time products, carefully
      read each label to ensure correct dosing.

    • mL= milliliter
                    Age                                                                          Dose
     Adults & children 12 years and over 30 mL every 6 hours
     Children 4 to under 12 years Ask a doctor
     Children under 4 years of age Do not use

  • OTHER SAFETY INFORMATION

    Other information
    • each 30 mL contains: sodium 10 mg
    • store at room temperature
    • dosing cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

  • QUESTIONS

    Ouestions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Principal Display Panel

    CVS
    HealthTM


    Compare to the
    active ingredients in
    Vicks® NyQuil® Cough*

    Nighttime
    Cough

    Free of alcohol, dyes &
    artificial sweeteners

    DEXTROMETHORPHAN HBr
    Cough suppressant

    DOXYLAMINE SUCCINATE
    Antihistamine

    Relieves:
    • Cough
    • Sneezing
    • Runny nose

    Cherry Flavor

    ForAges
    12 & Over

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    *This product is not manufactured or distributed by Proctor
    & Gamble, owner of the registered trademarks Vicks®
    and NyQuil®.

    Lot:
    Exp:

    LR-106     #442933

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2018 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-34874

    √CVS Quality

    Moneu Back Guarantee

    308-26 Label

                                                        Nighttime Cough Relief by CVS Pharmacy, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH 
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-308
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-308-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-308)

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