Label: MECLIZINE- meclizine hcl 12.5mg tablet

  • NDC Code(s): 73057-386-08, 73057-386-11
  • Packager: Ulai Health LLC
  • 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 July 22, 2019

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

  • Active ingredient (in each caplet)

    Meclizine HCl 12.5 mg

  • Purpose

    Antiemetic

  • Uses

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

  • Warnings

  • Do not use

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

    Do not take this product, unless directed by a doctor, if you have

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

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

  • When using this product

    • do not exceed recommended dosage
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use causion 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 (1-800-222-1222).

  • Directions

    • dosage should be taken one hour before travel starts
    adults and children 12 years and overtake 2 or 4 caplets once daily or as directed by a doctor 

  • Other information

    • each caplet contains: calcium 28 mg
    • store at 20o-25°C (68o-77°F)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or comments?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-386-11

    Manufactured in the USA

    Motion Sickness Relief

    MECLIZINE

    Meclizine HCl 12.5 mg

    Antiemetic

    • Motion Sickness • Nausea • Vomiting

    1000 CAPLETS

    Ulai Meclizine 12.5 mg Caplet 1000 ct. Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 12.5mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-386
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULE (Capsule shaped tablet) Size13mm
    FlavorImprint Code PH049
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-386-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
    2NDC:73057-386-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/08/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(73057-386) , analysis(73057-386) , pack(73057-386) , label(73057-386)