Label: MECLIZINE- meclizine hcl 12.5 mg tablet

  • 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 April 25, 2019

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

  • Active ingredient (in each caplet)

    Meclizine HCl 12.5mg

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  • Purpose

    Antiemetic

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  • Uses

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

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  • 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.

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  • Directions

    • dosage 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

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  • 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)
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  • Inactive ingredients

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

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  • Questions?

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

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  • HOW SUPPLIED

    Product: 50090-3017

    NDC: 50090-3017-3 30 TABLET in a BOTTLE

    NDC: 50090-3017-7 28 TABLET in a BOTTLE

    NDC: 50090-3017-8 90 TABLET in a BOTTLE

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  • Meclizine HCl 12.5 mg
  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3017(NDC:16103-386)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE (CAPSULE SHAPED TABLET) Size 13mm
    Flavor Imprint Code PH049
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50090-3017-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018
    2 NDC:50090-3017-7 28 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2018
    3 NDC:50090-3017-8 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/09/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 02/01/2018
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    Name Address ID/FEI Business Operations
    A-S Medication Solutions 830016429 RELABEL(50090-3017) , REPACK(50090-3017)
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