Label: POLY HIST PD- thonzylamine hydrochloride and chlophedianol hydrochloride liquid 

  • Label RSS
  • NDC Code(s): 50991-222-45
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    6.25 mg Thonzylamine HCl per 1 mL

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  • Purpose

    Antihistamine

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  • Active ingredients

    6.25 mg Chlophedianol HCl per 1 mL

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  • Purpose

    Antitussive

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  • Uses

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

    • cough due to minor throat and bronchial irritation
    • calms the cough control center and relieves coughing
    • runny nose
    • sneezing
    • itching of the nose and throat
    • itchy, watery eyes
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  • Warnings

    Ask a doctor before use if

    a child has

    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if

    a child is taking sedatives or tranquilizers. 

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
    • new symptoms occur

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately. 

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  • Directions

    Do not exceed recommended dosage.

    • Use only with enclosed dropper
    • Do not use enclosed dropper for any other drug product

    Children 2 to under 6 years of age: 2 mL every 6 hours not to exceed 8 mL in 24 hours, or as directed by a doctor

    Children under 2 years of age: consult a doctor

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  • Other information

    Store at 20°-25°C (68°-77°F); excursions
    permitted to 15°-30°C (59°-86°F).
    [See USP Controlled Room Temperature].

    Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

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  • Inactive ingredients

    Citric Acid, Magnasweet, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol, Strawberry Flavor, Sucralose

     

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  • Questions?

    Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).

    Manufactured for Poly Pharmaceuticals,
    Quitman, MS 39355

    Rev. 06/13

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  • PRINCIPAL DISPLAY PANEL

    NDC 50991-222-45
    Poly-
    Hist PD
    Liquid

    Antihistamine /
    Antitussive
    4
    5 mL Strawberry Flavor

    PRINCIPAL DISPLAY PANEL
NDC 50991-222-45
Poly-Hist PD
Liquid
Antihistamine / Antitussive
45 mL Strawberry Flavor

    PRINCIPAL DISPLAY PANEL
NDC 50991-222-45
Poly-Hist PD
Liquid
Antihistamine / Antitussive
45 mL Strawberry Flavor

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  • INGREDIENTS AND APPEARANCE
    POLY HIST PD 
    thonzylamine hydrochloride and chlophedianol hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50991-222
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THONZYLAMINE HYDROCHLORIDE (THONZYLAMINE) THONZYLAMINE HYDROCHLORIDE 6.25 mg  in 1 mL
    CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE 6.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    AMMONIUM GLYCYRRHIZATE  
    METHYLPARABEN  
    POTASSIUM CITRATE  
    POTASSIUM SORBATE  
    PROPYLPARABEN  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    SUCRALOSE  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50991-222-45 45 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2013
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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