Label: MECLIZINE HCL- meclizine hydrochloride chewable 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 March 28, 2022

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  • Active Ingredients (in each chewable tablet)

    Meclizine HCl, USP 25 mg

  • 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 DOCTOR/PHARMACIST

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

  • When using this product

    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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.

    In case of overdose, get medical help or contact the poison control center immediately

  • Directions

    • Dosage should be taken one hour before travel starts
    • Adults and children 12 years and older: Chew 1-2 tablets once daily, or as directed by a doctor
    • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

  • Other information

    • Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
    • Store at room temperature in a dry place
    • Keep lid tightly closed
  • Inactive ingredients

    aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

  • Questions or Comments?

    Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by:
    Drug Ocean Logo
    Drug Ocean LLC,
    221 River Street, Suite 9051,
    Hoboken, NJ 07030

    Manufactured by:

    Unique Pharmaceutical Laboratories
    (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
    Mumbai 400 030, India

    ORG 07/21

  • PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

    NDC 70985-010-01
    Meclizine Hydrochloride Chewable Tablets 25mg
    (ANTIEMETIC)
    Travel Sickness
    100 tablets

    Front panelBack Panel

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride chewable tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-010
    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
    SUCROSE (UNII: C151H8M554)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorpink (Pink to light pink) Score2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70985-010-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/28/2022
    Labeler - Drug Ocean LLC (080381835)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(70985-010)
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