Label: MECLIZINE- meclizine hcl 25mg tablet, chewable

  • NDC Code(s): 66424-387-01, 66424-387-10
  • Packager: SDA Laboratories, 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 February 1, 2018

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

  • Active ingredient (in each tablet)

    Meclizine HCl 25mg

    Close
  • Purpose

    Antiemetic

    Close
  • Uses

    prevents and treats nausea, vomiting or dizziness associated with motion sickness

    Close
  • Warnings

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

    Do not take unless directed by a doctor if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product

    • do not exceed recommended dosage
    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    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 a Poison Control Center right away.

    Close
  • Directions

    • doage should be taken 1 hour before travel starts  
    Adults and children 12 years and over

    take 1 or 2 tablets once daily or as directed by doctor

    Close
  • Other information

    • Tamper Evident: do not use if safety seal under cap is broken or missing
    • store at room temperature 20°-25°C (68°-77°F)
    Close
  • Inactive ingredients

    Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

    Close
  • Questions?

    Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 66424-0387-01

    *Compare to the active ingredient in Bonine®

    MECLIZINE

    CHEWABLE

    Raspberry Flavor

    Meclizine HCl 25mg

    Anti-Emetic

    • Motion Sickness • Nausea • Vomiting

    100 TABLETS

    SDA

    LABORATORIES

    SDA Meclizine 25 mg Tablet Package Label

    Close
  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 25mg tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-387
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color pink (LIGHT PINK COLOR) Score 2 pieces
    Shape ROUND (ROUND TABLET) Size 8mm
    Flavor Imprint Code PH051
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66424-387-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018
    2 NDC:66424-387-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 02/01/2018
    Labeler - SDA Laboratories, Inc. (948067889)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceuticals, Inc. 557054835 manufacture(66424-387) , pack(66424-387) , analysis(66424-387)
    Close