Label: MEDIQUE MEDI-MECLIZINE- meclizine hcl tablet

  • NDC Code(s): 47682-481-15, 47682-481-33, 47682-481-99
  • Packager: Unifirst First Aid Corporation
  • 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 30, 2022

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Meclizine Hydrochloride 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

    for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

  • WARNINGS

    Warnings

  • DO NOT USE

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

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ difficulty in urination due to enlargement of the prostate gland

    ■ glaucoma

    ■ a breathing problems such as emphysema or chronic bronchitis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product

    ■ drowsiness may occur

    ■ avoid alcoholic beverages

    ■ alcohol, sedatives and tranquilizers may increase drowsiness

    ■ use caution when driving a motor vehicle or operating machinery

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center
    (1-800-222-1222) right away.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity

    ■ to treat motion sickness, take at first signs of symptoms

    Adults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.

  • OTHER SAFETY INFORMATION

    Other information

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

    ■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)

    ■ protect from heat and humidity

    ■ use by expiration date on packet

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, D&C yellow # 10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

  • QUESTIONS

    Questions or comments? Call 1-800-634-7680

  • Medique Medi-Meclizine Label

    Medique®

    Medi-Meclizine

    All Day Relief

    Alivio que Perdura Todo el Dia

    Pull to Open

    Tire Para Abrir

    For the Prevention and Treatment of Motion Sickness • Meclizine HCl 25mg

    Para la Prevencion y el Tratamiento del Mareo “Mal del Viajero” • Hidrochloruro de Meclizina 25mg

    100 Tablets

    (50 x 2)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

    479R

  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-MECLIZINE 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-481
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-481-992 in 1 PACKET; Type 0: Not a Combination Product12/14/2020
    2NDC:47682-481-15500 in 1 BOX12/14/2020
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-481-3350 in 1 BOX12/14/2020
    32 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33612/14/2020
    Labeler - Unifirst First Aid Corporation (832947092)