Label: MECLIZINE HYDROCHLORIDE tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 February 13, 2023

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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 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

    TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

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

  • HOW SUPPLIED

    Each round chewable pink scored tablet imprinted with 5172 has a vanilla raspberry smell.

    Bottles of 12 NDC 72789-250-12

    Bottles of 20 NDC 72789-250-20

    Bottles of 30 NDC 72789-250-30

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

    Keep container tightly closed. Dispense in a tight, light-resistant container, as defined in the USP using a child-resistant closure.

  • PRINCIPAL DISPLAY PANEL

    Meclizibe 25 mg

    Antiemetic

    72789250 Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-250(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:72789-250-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
    2NDC:72789-250-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
    3NDC:72789-250-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00910/30/2020
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(72789-250)
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