Label: DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE tablet

  • NDC Code(s): 69367-197-60
  • 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
    Dexbrompheniramine Maleate 2 mgAntihistamine
    Phenylephrine HCL 10 mgNasal Decongestant
  • Uses

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

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • 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

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

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

    When using this product

    • excitability may occur, especially in children
    • may cause 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.

    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 to 6 hours, not to exceed 6 tablets in 24 hours or as directed by doctor.
    Children 6 to under 12 years of age:1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours or as directed by doctor.
    Children under 6 years of age:Consult a doctor.
  • Other Information

    Store at 15º-30ºC (59º-86ºF). Supplied in a tight, light resistant container with a child-resistant cap. Dexbrompheniramine Maleate and Phenylephrine HCl tablets are purple, oval shaped, scored tablets, debossed "WP" bisect "197" on one side and plain on the other.

  • Inactive ingredients

    Croscarmellose sodium, D&C Red #27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide.

  • Questions? Comments?

    Call 1-844-221-7294

  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

    NDC 69367-197-60

    Dexbrompheniramine Maleate
    and Phenylephrine HCl

    Antihistamine • Nasal Decongestant

    Each tablet contains:
    Dexbrompheniramine Maleate
    2 mg
    Phenylephrine HCl
    10 mg

    60 Tablets

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    DEXBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE 
    dexbrompheniramine maleate and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-197
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code WP;197
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-197-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/25/201806/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/25/201806/03/2024
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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