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SEA-CALM (Bellegrove)

Available Formats

Dosage Form Package Information Links
TABLET, CHEWABLE 2 TABLET, CHEWABLE in 1 PACKET (59961-123-01) Label Information

Complete SEA-CALM Information

  • Active ingredient

    Meclizine Hydrochloride 25 mg


  • Purpose

    Antiemetic


  • Uses

    For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness


  • Warnings

    Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not give to children under 12 years of age unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.


  • Directions

    Adult oral dosage is one to two tablets once daily or as directed by a physician.


  • Inactive ingredients

    Crosscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.


  • Package/Label Principal Display Panel

    Container Label for SEA-CALM Packet - 2 Tablets


  • INGREDIENTS AND APPEARANCE
    SEA-CALM 
    meclizine hcl 25mg chewable tablets tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59961-123
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    CROSPOVIDONE (UNII: 68401960MK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    RASPBERRY (UNII: 4N14V5R27W)  
    VANILLA (UNII: Q74T35078H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 9mm
    Flavor FRUIT Imprint Code BMS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59961-123-01 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 03/16/2009
    Labeler - Bellegrove (070966486)
    Registrant - Contract Pharmacal Corporation (057795122)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corporation 057795122 MANUFACTURE