Label: MECLIZINE 25- meclizine hydrochloride tablet, chewable

  • NDC Code(s): 43063-804-01, 43063-804-12, 43063-804-20
  • Packager: PD-Rx Pharmaceuticals, Inc.
  • 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 February 8, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredients (in each chewable tablet)

    Meclizine 25 mg

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  • Purpose

    Antiemetic

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  • Indications and Usage

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

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  • 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

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  • 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.
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  • Inactive ingredients

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

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  • Questions?

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

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  • How Supplied

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

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

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  • 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.

    43063804 Label

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  • INGREDIENTS AND APPEARANCE
    MECLIZINE 25 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-804
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code PH;051
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43063-804-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/27/2017 11/30/2027
    2 NDC:43063-804-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018 11/30/2027
    3 NDC:43063-804-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/08/2018 11/30/2027
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 11/27/2017 11/30/2027
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    Name Address ID/FEI Business Operations
    PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-804)
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