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
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 27, 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
    unapproved drug other06/01/2019
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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