Label: MECLIZINE HYDROCHLORIDE tablet, chewable

  • 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 June 3, 2021

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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

     Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

     store at room temperature in a dry place

     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

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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

    *This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Meclizine Hydrochloride

    GENERIC: Meclizine Hydrochloride

    DOSAGE: TABLET, CHEWABLE

    ADMINSTRATION: ORAL

    NDC: 70518-3015-0

    NDC: 70518-3015-1

    NDC: 70518-3015-2

    COLOR: pink

    FLAVOR: VANILLA

    SHAPE: ROUND

    SCORE: Two even pieces

    SIZE: 9 mm

    IMPRINT: 5172

    PACKAGING: 10 in 1 BOTTLE, PLASTIC

    PACKAGING: 30 in 1 BLISTER PACK

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • MECLIZINE HYDROCHLORIDE 25mg in 1

    INACTIVE INGREDIENT(S):

    • CROSPOVIDONE
    • VANILLA
    • MAGNESIUM STEARATE
    • RASPBERRY
    • STEARIC ACID
    • FD&C RED NO. 40
    • LACTOSE MONOHYDRATE
    • SACCHARIN SODIUM
    • CROSCARMELLOSE SODIUM
    • SILICON DIOXIDE

    Remedy_Label

    MM2

    MM3

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3015(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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink (Rosy) Score2 pieces
    ShapeROUNDSize9mm
    FlavorVANILLA, RASPBERRYImprint Code 5172
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-3015-010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2021
    2NDC:70518-3015-130 in 1 BLISTER PACK; Type 0: Not a Combination Product02/08/2021
    3NDC:70518-3015-230 in 1 BLISTER PACK; Type 0: Not a Combination Product06/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/03/2021
    Labeler - REMEDYREPACK INC. (829572556)
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