Label: MECLIZINE HCL- meclizine hydrochloride chewable tablet, chewable

  • NDC Code(s): 16571-824-01, 16571-824-10
  • Packager: Rising 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 August 18, 2022

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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

  • PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

    Meclizine Hydrochloride Chewable Tablets

    25 mg

    100 Tablets / 1000 tablets

    meclizine-100ct

    meclizine-1000ct

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride chewable tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 (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:16571-824-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2022
    2NDC:16571-824-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/18/2022
    Labeler - Rising Pharmaceuticals, Inc. (835513529)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(16571-824)
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