Label: MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable

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

Drug Label Information

Updated October 6, 2023

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  • Drug Facts Active ingredient (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 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

  • TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine® Manufactured by: Unique Pharmaceutical Laboratories(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.),Mumbai 400 030, India Distributed by:Rising Pharma Holdings, Inc.East Brunswick, NJ 08816 Mfg. Lic. No.: G/1430Feb 2022

    Repackaged By: Preferred Pharmaceutical Inc.

  • PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

    Meclizine Hydrochloride Chewable Tablets

    25 mg

    68788-8529

    Meclizine HCL 25mg Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride chewable tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8529(NDC:16571-824)
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)  
    SUCROSE (UNII: C151H8M554)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    Colorpink (Pink to light pink) Score2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8529-110 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
    2NDC:68788-8529-330 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug33610/06/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-8529)
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