DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET [WESTMINSTER PHARMACEUTICALS, LLC]

DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE TABLET [WESTMINSTER PHARMACEUTICALS, LLC]
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NDC 69367-199-01
Set ID 77679ca2-d913-44dc-826f-8b67d26793d7
Category HUMAN OTC DRUG LABEL
Packager Westminster Pharmaceuticals, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Doxylamine Succinate 7.5mgAntihistamine
    Phenylephrine HCl 10mgNasal Decongestant
  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

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

    When using this product

    • exctability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever

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

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.
    Children 6 to 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
    Children 6 years of age and under:Consult a physician.
  • Other Information

    Store at 15°-30°C (59°-86°F)

    Supplied in a tight, light-resistant container with a child-resistant cap. Doxylamine Succinate and Phenylephrine HCl tablets are light blue, caplet shaped, scored tablets, debossed "WP" bisect "199" on one side and plain on the other.

  • Inactive ingredients

    FD&C Blue #2 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Silicone Dioxide, Sodium Starch Glycolate

  • Questions? Comments?

    Call 1-844-221-7294

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 69367-199-01

    Doxylamine Succinate
    and Phenylephrine HCl

    Antihistamine • Nasal Decongestant

    Each tablet contains:

    Doxylamine Succinate
    7.5 mg

    Phenylephrine HCl
    10 mg

    100 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE 
    doxylamine succinate and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-199
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE7.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize14mm
    FlavorImprint Code WP;199
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-199-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/25/2018
    Labeler - Westminster Pharmaceuticals, LLC (079516651)

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