Label: MECLIZINE- meclizine hcl 25mg tablet, chewable

  • NDC Code(s): 71335-1215-0, 71335-1215-1, 71335-1215-2, 71335-1215-3, view more
    71335-1215-4, 71335-1215-5, 71335-1215-6, 71335-1215-7, 71335-1215-8, 71335-1215-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 66424-387
  • 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 June 13, 2019

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  • Active ingredient (in each tablet)

    Meclizine HCl 25mg

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or 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
    • 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.

  • 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

  • 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)
  • 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 (800) 687-0176 (M - F, 8AM - 4PM EST).

  • HOW SUPPLIED

    Product: 71335-1215

    NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE

    NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE

  • Meclizine 25MG Chewable

    Label Image
  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 25mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1215(NDC:66424-387)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorpink (LIGHT PINK COLOR) Score2 pieces
    ShapeROUND (ROUND TABLET) Size8mm
    FlavorImprint Code PH051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1215-0120 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    2NDC:71335-1215-130 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    3NDC:71335-1215-220 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    4NDC:71335-1215-325 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    5NDC:71335-1215-440 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    6NDC:71335-1215-560 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    7NDC:71335-1215-690 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    8NDC:71335-1215-78 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    9NDC:71335-1215-814 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    10NDC:71335-1215-910 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/01/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1215) , RELABEL(71335-1215)
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