Label: LORATADINE- loratadine tablet

  • NDC Code(s): 63868-151-01, 63868-151-10, 63868-151-30
  • Packager: Chain Drug Marketing Association Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine USP, 10 mg

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  • PURPOSE

    Antihistamine

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  • USES

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
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  • WARNINGS

    Do not use

    If you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have

    Liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    Do not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

    An allergic reaction to this product occurs. Seek medical help right away.

    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

    adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
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  • OTHER INFORMATION

    • store between 20 and 25° C (68 and 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
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  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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  • QUESTIONS?

    Call 1-800-406-7984

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  • PRINCIPAL DISPLAY PANEL

    QC QUALITY CHOICE®

    NDC 63868-151-30

    *Compare to the active ingredient of Claritin®

    NON-DROWSY٭

    Allergy Relief

    Loratadine Tablets USP, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    Sneezing; Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    30 Tablets

    24 Hour

    Allergy Relief

    ٭When taken as directed. See Drug Facts Panel.

    ©DISTRIBUTED BY QUALITY CHOICE

    50693580908

    This is the 30 count blister carton label for Quality Choice Loratadine tablets USP, 10 mg.

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63868-151
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    STARCH, PREGELATINIZED CORN  
    Product Characteristics
    Color white (White to Off-White) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code RX526
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-151-10 10 in 1 BLISTER PACK
    2 NDC:63868-151-30 30 in 1 BLISTER PACK
    3 NDC:63868-151-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076134 08/19/2003
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(63868-151)
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