Label: MECLIZINE 25- meclizine hydrochloride tablet, chewable

  • NDC Code(s): 43063-804-01, 43063-804-06, 43063-804-12, 43063-804-20, view more
    43063-804-30
  • Packager: PD-Rx 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 27, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each chewable tablet)

    Meclizine 25 mg

  • Purpose

    Antiemetic

  • Indications and Usage

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

  • 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
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    • ask 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. 1-800-222-1222

  • Directions

    Dosage should be taken 1 hour befor travel starts.

    Adults and children 12 years and over:Take 1 or 2 tablets once daily, or as directed by doctor.
  • Inactive ingredients

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

  • Questions?

    Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).

  • How Supplied

    Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.

    Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.

  • PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label


    Antiemetic

    Each chewable tablet contains:

    Meclizine HCl

    25 mg

    Store at 68°-77°F (20°-25°C)

    Tamper evident by foil seal under cap.

    Do not use if foil seal is broken or missing.

    image

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 25 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-804
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code PH;051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43063-804-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/201711/30/2027
    2NDC:43063-804-2020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/201811/30/2027
    3NDC:43063-804-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/201811/30/2027
    4NDC:43063-804-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/201811/30/2027
    5NDC:43063-804-066 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/23/201811/30/2027
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/27/201711/30/2027
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-804)