Label: AHIST- chlorcyclizine hydrochloride tablet

  • NDC Code(s): 58407-025-01, 58407-025-06, 58407-025-30
  • Packager: Magna Pharmaceutcals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients (in each immediate-release tablet)

    Chlorcyclizine HCl 25 mg

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  • Purpose

    Antihistamine

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  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

    Do not exceed recommended dosage.

    Do not take this product unless directed by a doctor if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

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

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase drowsiness effect
    • Use caution when driving a motor vehicle or operating machinery.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

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  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over: 1 tablet by mouth every 6-8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
    Children 6 to under 12 years of age: ½ tablet by mouth every 6-8 hours, not to exceed 1½ tablets in 24 hours, or as directed by a doctor
    Children under 6 years of age Consult a doctor
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  • Inactive ingredients

    Lake Blend Green, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

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  • Questions or Comments?

    Call 1-888-206-5525

    www.magnaweb.com

    Rev. 12/12

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    MAGNA
    Pharmaceuticals, Inc.
    Louisville, KY 40299

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  • PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

    NDC 58407-025-30

    AHISTâ„¢

    Antihistamine

    Each tablet contains:

    Chlorcyclizine HCl 25 mg

    MAGNA
    Pharmaceuticals, Inc.
    Louisville, KY 40299

    30 Tablets

    Principal Display Panel - 30 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    AHIST 
    chlorcyclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58407-025
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORCYCLIZINE HYDROCHLORIDE (CHLORCYCLIZINE) CHLORCYCLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape OVAL Size 16mm
    Flavor Imprint Code AHIST;025
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58407-025-30 30 in 1 BOX
    1 NDC:58407-025-01 1 in 1 BLISTER PACK
    2 NDC:58407-025-06 6 in 1 BOX
    2 NDC:58407-025-01 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part341 01/15/2013
    Labeler - Magna Pharmaceutcals, Inc. (620988360)
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