Label: AHIST- chlorcyclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 4, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each immediate-release tablet)

    Chlorcyclizine HCl 25 mg

  • Purpose

    Antihistamine

  • 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
  • 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.

  • 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

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

  • Questions or Comments?

    Call 1-888-206-5525

    www.magnaweb.com

    Rev. 12/12

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

    NDC 58407-025-30

    AHIST™

    Antihistamine

    Each tablet contains:

    Chlorcyclizine HCl 25 mg

    MAGNA
    Pharmaceuticals, Inc.
    Louisville, KY 40299

    30 Tablets

    Principal Display Panel - 30 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    AHIST 
    chlorcyclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORCYCLIZINE - UNII:M26C4IP44P) CHLORCYCLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code AHIST;025
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58407-025-3030 in 1 BOX01/15/2013
    1NDC:58407-025-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58407-025-066 in 1 BOX01/31/201309/01/2019
    2NDC:58407-025-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/2013
    Labeler - Magna Pharmaceutcals, Inc. (620988360)