MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [SDA LABORATORIES, INC.]

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MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [SDA LABORATORIES, INC.]
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NDC 66424-386-01, 66424-386-10
Set ID f2581bc8-7845-4c65-b5cf-fbce48768fb9
Category HUMAN OTC DRUG LABEL
Packager SDA Laboratories, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each caplet)

    Meclizine HCl 12.5mg

  • 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 2 or 4 caplets 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, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 66424-0386-10

    MECLIZINE

    Meclizine HCl 12.5mg

    Anti-Emetic

    • Motion Sickness • Nausea • Vomiting

    1000 CAPLETS

    SDA

    LABORATORIES

    SDA Meclizine 12.5 mg Caplet Package Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-386
    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
    Colorwhite (WHITE COLOR) Scoreno score
    ShapeCAPSULE (CAPSULE SHAPED TABLET) Size13mm
    FlavorImprint Code PH049
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66424-386-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    2NDC:66424-386-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33602/01/2018
    Labeler - SDA Laboratories, Inc. (948067889)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(66424-386) , pack(66424-386) , analysis(66424-386)
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