Label: STAHIST AD- chlorcyclizine hydrochloride and pseudoephedrine hydrochloride tablet

  • NDC Code(s): 58407-625-01, 58407-625-06, 58407-625-30
  • Packager: Magna 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 12/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients
    (in each immediate-release tablet)
    Purpose
    Chlorcyclizine HCl 25 mg Antihistamine
    Pseudoephedrine HCl 60 mg Nasal Decongestant
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  • 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, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
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  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains 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
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes melitus
    • 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
    • avoid alcoholic beverages
    • 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
    • new symptoms occur

    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

    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

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  • Questions or Comments?

    Call 1-888-206-5525 • www.magnaweb.com

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  • SPL UNCLASSIFIED SECTION

    Rev. 10/11

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  • PRINCIPAL DISPLAY PANEL - 25 mg/60 mg Tablet Carton

    NDC 58407-625-30

    Antihistamine • Nasal Decongestant

    Stahist AD

    Each tablet contains:
    Chlorcyclizine HCl 25 mg
    Pseudoephedrine HCl 60 mg

    MAGNA
    Pharmaceuticals, Inc.
    Louisville, KY 40299

    30 Tablets

    PRINCIPAL DISPLAY PANEL - 25 mg/60 mg Tablet Carton

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  • INGREDIENTS AND APPEARANCE
    STAHIST AD 
    chlorcyclizine hydrochloride and pseudoephedrine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58407-625
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORCYCLIZINE HYDROCHLORIDE (CHLORCYCLIZINE) CHLORCYCLIZINE HYDROCHLORIDE 25 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL Size 16mm
    Flavor Imprint Code M625
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58407-625-30 1 in 1 BOX
    1 30 in 1 BOTTLE
    2 NDC:58407-625-06 6 in 1 BOX
    2 NDC:58407-625-01 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/20/2011
    Labeler - Magna Pharmaceuticals, Inc. (620988360)
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