MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [RITE AID CORPORATION]

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MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [RITE AID CORPORATION]
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NDC 11822-0404-2
Set ID 1d2f5ae4-8a0a-455e-87d1-61d7d07d3455
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each chewable tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • Warnings

    Do not use

    for children under 12 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery
    • drowsiness may occur

    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

    • dosage should be taken one hour before travel starts
    • chew or crush tablets completely before swallowing; do not swallow tablets whole
    • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    NDC 11822-0404-2

    Compare to the active ingredient in Bonine® Chewable Tablets*

    MOTION SICKNESS RELIEF
    MECLIZINE HCl 25 mg CHEWABLE TABLETS
    ANTIEMETIC
    PREVENTS MOTION SICKNESS

    RASPBERRY
    FLAVORED

    16 CHEWABLE TABLETS

    ACTUAL SIZE

    chew or crush tablets completely
    before swallowing.

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Insight Pharmaceuticals LLC, owner of the registered trademark Bonine® Chewable Tablets.
    50844         REV1218C40421

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE,
    CAMP HILL, PA 17011
    www.riteaid.com

    SATISFACTION
    GUARANTEE
    If you're not satisfied, we'll
    happily refund your money.

    Rite Aid 44-404

    Rite Aid 44-404

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0404
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorpink (Light Pink) Score2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRYImprint Code 44;404
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0404-22 in 1 CARTON05/29/2002
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-0404-41 in 1 CARTON05/29/2002
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33605/29/2002
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11822-0404)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(11822-0404)
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