Label: POLY HIST FORTE- doxylamine succinate and phenylephrine hydrochloride tablet

  • NDC Code(s): 50991-626-01, 50991-626-02
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each tablet)

    Doxylamine Succinate 10.5mg

  • Purpose

    Antihistamine

  • Active ingredients

    (in each tablet)

    Phenylephrine HCl 10 mg            

  • Purpose

    Nasal Decongestant

  • Uses

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

    • nasal congestion
    • reduces swelling of nasal passages
    • runny nose
    • sneezing
    • itching of nose or throat
    • itchy, watery eyes
  • 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
    • trouble urinating due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
  • Ask a doctor before use if

    you are taking sedatives or tranquilizers.

  • When using this product

    • excitability 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.

    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 younger:           		 Consult a physician.
  • Other information

    Store at controlled room temperature between 15°-30°C (59°-86°F).

    Supplied in a tight, light-resistant container with a child-resistant cap.

    Poly Hist Forte Tablets are blue, caplet-shaped, scored tablets, debossed "Poly" bisect "216" on one side and plain on the other.

  • Inactive ingredients

    FD&C Blue # 2, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

  • Questions? Comments?

    Call 1-800-882-1041

    Manufactured for:

    Poly Pharmaceuticals, Inc.

    Huntsville, AL Rev. 4/16

  • PRINCIPAL DISPLAY PANEL

    NDC 50991-626-01

    POLY HIST FORTE ®

    TABLETS

    Nasal Decongestant • Antihistamine

    NEW FORMULA

    Each tablet contains:

    Doxylamine Succinate . . . 10.5 mg

    Phenylephrine HCl . . . . . . 10 mg

    100 Tablets

    backlabel

  • INGREDIENTS AND APPEARANCE
    POLY HIST FORTE 
    doxylamine succinate and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-626
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE10.5 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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScore2 pieces
    ShapeCAPSULESize14mm
    FlavorImprint Code Poly;216
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-626-0212 in 1 CARTON06/01/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50991-626-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2019
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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