Label: MECLIZINE HYDROCHLORIDE- meclizine hcl 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 November 22, 2022

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

View All Sections
  • Active ingredient (in each chewable tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    For the prevention and treatment of these symptoms associated
    with motion sickness • nausea • vomiting • dizziness

  • Warnings

    Do not use

    for children under 12 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • glaucoma
    • breathing problems, such as emphysema or chronic bronchitis
    • difficulty urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • drowsiness may occur
    • avoid alcoholic beverages 
    • use caution 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.

  • Directions

    • do not exceed recommended dose
    • dosage should be taken one hour before travel starts
    • chew or crush tablets completely before swallowing;do not swallow tablets whole
    • adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by a doctor
  • Other information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing.
    • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from humidity
  • Inactive ingredients

    corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

  • Questions or comments?

    1-800-540-3765

  • Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-779
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRYImprint Code 44;404
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80136-779-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/01/2022
    Labeler - NORTHEAST PHARMA (081232935)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!