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

Drug Label Information

Updated October 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    (in each immediate-release tablet)     		Purpose
    Chlorcyclizine HCl 25 mgAntihistamine
    Pseudoephedrine HCl 60 mgNasal Decongestant
  • 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
  • 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.

  • 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 ageConsult a doctor
  • Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

  • Questions or Comments?

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

  • SPL UNCLASSIFIED SECTION

    Rev. 10/11

  • PRINCIPAL DISPLAY PANEL

    Stahist AD Principal Display Panel

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    STAHIST AD 
    chlorcyclizine hydrochloride and pseudoephedrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-625
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P) CHLORCYCLIZINE HYDROCHLORIDE25 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code M625
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58407-625-301 in 1 BOX12/20/2011
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58407-625-066 in 1 BOX12/20/2011
    2NDC:58407-625-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58407-625-011 in 1 BLISTER PACK; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/20/2011
    Labeler - Magna Pharmaceuticals, Inc. (620988360)
    Registrant - Wittman Pharma, Inc. (830980947)
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