Label: DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE tablet

  • NDC Code(s): 69367-199-01
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 26, 2018

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  • 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, Magnesium Stearate, Microcrystalline Cellulose, Silicon 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 (UNII: L06K8R7DQK)  
    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 Product10/25/201805/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/25/201805/01/2024
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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