Label: ALAHIST PE- dexbrompheniramine maleate, phenylephrine hydrochloride tablet

  • NDC Code(s): 50991-788-02, 50991-788-90
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 27, 2024

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  • Active Ingredients

    (in each tablet)
    Dexbrompheniramine Maleate 2 mg
    Phenylephrine Hydrochloride 7.5 mg

  • Purpose


    Dexbrompheniramine Maleate- -Antihistamine
    Phenylephrine Hydrochloride-- Nasal 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, water eyes
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    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 enlargement 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 Doctor if

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

    If Pregnant or Breastfeeding

    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

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor.
    Children under 6 years of age: Consult a doctor.

  • Other Information

    Store at 15°-30°C (59°-86°F). Supplied in a tight,light-resistant container with a child-resistant cap. Alahist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" 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 1-800-882-1041

  • Alahist PE Label

    Manufactured for

    Poly Pharmaceuticals
    Huntsville, AL 35763

    labelback

  • INGREDIENTS AND APPEARANCE
    ALAHIST PE 
    dexbrompheniramine maleate, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-788
    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 HYDROCHLORIDE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorpurpleScore2 pieces
    ShapeCAPSULESize11mm
    FlavorImprint Code Poly;782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-788-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    2NDC:50991-788-0212 in 1 BLISTER PACK; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2020
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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