Label: SEA-CALM- meclizine hcl 25mg chewable tablets tablet, chewable

  • 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 9, 2010

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:59961-123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScore2 pieces
    ShapeROUNDSize9mm
    FlavorFRUITImprint Code BMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59961-123-012 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/16/2009
    Labeler - Bellegrove (070966486)
    Registrant - Contract Pharmacal Corporation (057795122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation057795122MANUFACTURE
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