Label: MECLIZINE 25- meclizine hydrochloride tablet, chewable

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

Drug Label Information

Updated February 28, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each chewable tablet)

    Meclizine 25 mg

  • Purpose

    Antiemetic

  • Indications and Usage

    prevents and treats nausea, vomiting, dizziness associated with motion sickness:

  • Warnings

    • Do not use for children under 12 years of age unless directed by a doctor.

    Do not take unless directed by a doctor if you have

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

    Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    • ask 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 1 hour befor travel starts.

    Adults and children 12 years and over:Take 1 or 2 tablets once daily, or as directed by doctor.
  • Inactive ingredients

    Croscarmellose sodium, dextrose, FD& C Red #40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

  • Questions?

    Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).

  • How Supplied

    Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.

    Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.

  • PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label


    Antiemetic

    Each chewable tablet contains:

    Meclizine HCl

    25 mg

    Store at 68°-77°F (20°-25°C)

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or missing.

    image

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 25 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-804(NDC:16103-387)
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink (LIGHT PINK COLOR) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code PH051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43063-804-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/2017
    2NDC:43063-804-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    3NDC:43063-804-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2018
    4NDC:43063-804-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2018
    5NDC:43063-804-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00911/27/2017
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-804)
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