Label: MECLIZINE HYDROCHLORIDE tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 10, 2024

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  • Drug Facts

    Active ingredient (in each chewable tablet)
    Meclizine HCl 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or dizziness due to motion sickness

  • WARNINGS

    Do not use in

    children under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have

     glaucoma

     a breathing problem such as emphysema or chronic bronchitis
     trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    you are taking sedatives or tranquilizers

    When using this product

     Do not exceed recommended dosage

     may cause drowsiness

     alcohol, sedatives, and tranquilizers may increase drowsiness

     avoid alcoholic drinks
     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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

     Dosage should be taken one hour before travel starts

    adults and children 12
    years of age and over     		chew 1 to 2 tablets once daily, or as directed by a doctor
    children under
    12 years of age     		do not give this product to children under 12 years of age
    unless directed by a doctor

  • Other information

     Store in a dry place at 15°-30°C (59°-86°F)
     keep lid tightly closed

  • INACTIVE INGREDIENT

    Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

    Distributed by:
    RUGBY® LABORATORIES
    Indianapolis, IN 46268
    www.rugbylaboratories.com

  • REPACKAGING INFORMATION

    Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    25mg
    NDC 71610-836-30, Bottles of 30 Tablets
    NDC 71610-836-53, Bottles of 60 Tablets
    NDC 71610-836-60, Bottles of 90 Tablets
    NDC 71610-836-80, Bottles of 180 Tablets



    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:

    Aphena
    Cookeville, TN 38506

    20240529AMH

  • PRINCIPAL DISPLAY PANEL - 25mg

    NDC 71610-836 - Meclizine 25mg Tablets - Rx Only

    Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-836(NDC:0536-1299)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    VANILLA (UNII: Q74T35078H)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    RASPBERRY (UNII: 4N14V5R27W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Colorpink (Rosy) Score2 pieces
    ShapeROUNDSize9mm
    FlavorVANILLA, RASPBERRYImprint Code 5172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-836-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    2NDC:71610-836-5360 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    3NDC:71610-836-6090 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    4NDC:71610-836-80180 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00910/30/2020
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC 128385585repack(71610-836)
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