NIGHTTIME COUGH RELIEF CHERRY (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [PHARMACY VALUE ALLIANCE, LLC]

NIGHTTIME COUGH RELIEF CHERRY (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [PHARMACY VALUE ALLIANCE, LLC]
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NDC 68016-238-08
Set ID f7323a2b-1777-4d8f-a2ca-328bf2018d97
Category HUMAN OTC DRUG LABEL
Packager Pharmacy Value Alliance, LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients  (in each 30 mL dose cup)
    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 aprescription 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 enlarged prostate gland.

  • ASK DOCTOR/PHARMACIST

    Ask adoctor 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 • cough lasts more than 7 days,
    comes back, or occurs with fever, rash, or headache that lasts.
    These could be signs of a serious 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 or tablespoon (TBSP)
    • do not exceed 4 doses per 24 hours
    • When using Day Time and Night Time products, carefully read
    each label to ensure correct dosing.

    adults & children 12                  30 mL (2 TBSP)
    years and over                          every 6 hours

    children 4 to under 12 years       ask a doctor

    children under 4 years                do not use

  • OTHER SAFETY INFORMATION

    Other information
    • each 30 mL dose cup contains: sodium 45 mg
    • store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, FD&C Blue No.
    1, FD&C Red No. 40, .flavor, glycerin, polyethylene glycol,
    propylene glycol, purified water, saccharin sodium,
    sodium benzoate, sodium citrate, sucrose

  • QUESTIONS

    Ouestions? Call weekdays from 9:30 am to 4:30 pm
    EST. 1-877-798-5944.

  • Principal Display Panel

    Premier Value®

    COMPARE TO THE ACTIVE
    INGREDIENTS IN
    VICKS® NYQUIL®* COUGH*

    COUGH

    Nighttime Cough Relief

    Dextromethorphan HBr...... Cough Suppressant
    Doxylamine Succinate ......Antihistamine

    • Cough
    • Sneezing
    • Runny Nose

    Cherry Flavor

    8 FL OZ (237 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

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

    Questions? Call weekdays 1-877-798-5944.

    *This product is not manufactured or distributed by
    Proctor & Gamble owner of the registered
    trademark Vicks® NyQuil® Cough

    DISTRIBUTED BY:
    PHARMACY VALUE ALLIANCE, LLC
    407 EAST LANCASTER AVENUE,
    WAYNEPA 19087

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    If for any reason you are not satisfied
    with this product, please return it to the
    store where purchased for a full refund.

    LR-039
    REV 01

    Product Label - Nighttime Cough Relief - 8 OZ Package

    238-08 8 OZ

                                              Premier Value® Nighttime Cough Relief Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COUGH RELIEF  CHERRY
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-238
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-238-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2018
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(68016-238)

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