Label: RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl 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 March 10, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Meclizine HCl, USP 12.5 mg

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  • PURPOSE

    Purpose

    Antiemetic

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  • INDICATIONS & USAGE

    Uses

    prevents and treats nausea, vomiting or dizziness due to motion sickness

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  • WARNINGS

    Warnings

    Do not use in children under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    • ‚Äčmay cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution 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 the poison control center immediately.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Dosage should be taken one hour before travel starts.
    • Adults and children 12 years of age and older: take 2-4 caplets once daily, or as directed by a doctor
    • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

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  • STORAGE AND HANDLING

    Other information

    • Each Caplet Contains: Calcium 25 mg
    • store at room temperature in a dry place
    • Keep lid tightly closed
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  • INACTIVE INGREDIENT

    Inactive ingredients

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

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  • QUESTIONS

    Questions or comments?

    call 1-800-645-2158

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  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Rugby Laboratories

    17177 N. Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

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  • INGREDIENTS AND APPEARANCE
    RUGBY  MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3063(NDC:0536-1017)
    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)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white Score 2 pieces
    Shape CAPSULE (modified capsule shaped uncoated tablet with bisect) Size 3mm
    Flavor Imprint Code 19G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68071-3063-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017
    2 NDC:68071-3063-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017
    3 NDC:68071-3063-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017
    4 NDC:68071-3063-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/10/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 03/07/2014
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    Name Address ID/FEI Business Operations
    NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3063)
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