Label: MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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,
    1 Bridge Plaza, North Central Road

    6th Floor, Suite 675

    Fort Lee, NJ 07024

    Manufactured by:

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

    ORG 12/23

  • PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

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

    25 mg-100 count

  • 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 DrugM00902/28/2022
    Labeler - Drug Ocean LLC (080381835)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(70985-010)