LORATADINE TABLET [SUNMARK]

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  • LORATADINE TABLET [SUNMARK]

LORATADINE TABLET [SUNMARK]
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NDC 49348-112-01, 49348-112-13, 49348-112-44
Set ID fea30ab2-45bc-409b-8296-a4b4f71a4a99
Category HUMAN OTC DRUG LABEL
Packager Sunmark
Generic Name
Product Class
Product Number
Application Number ANDA075209
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  • Active Ingredient (in each tablet)

    Loratadine, USP 10 mg

  • Purpose

    Antihistamine

  • 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
  • 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. (1-800-222-1222)

  • 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
  • Other Information

    •
    Safety sealed: do not use if printed foil under cap is broken or missing. (for bottle only)
    •
    Safety sealed: do not use if the imprinted blister unit is open or torn. (for blister package only)

    •
    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    •
    Protect from excessive moisture. (for blister package only)
  • Inactive Ingredients

    Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

  • Questions or comments?

    1-800- 206-7821

    01-2016M

    Distributed by McKesson

    One Post Street, San Francisco, CA 94104

  • 10 mg Label

    Loratadine 10 mg Label

    sunmark®

    COMPARE TO CLARITIN® TABLETS

    ACTIVE INGREDIENT**

    NDC 49348-112-44

    24 Hour

    loratadine

    tablets, USP 10 mg

    Antihistamine

    *When taken

    as directed.

    See drug

    facts panel.

    GLUTEN FREE

    24 hour relief of sneezing, runny nose,

    itchy, watery eyes, itchy throat or nose

    Indoor and Outdoor Allergies

    NON-DROWSY*

    SAFETY SEALED: DO NOT USE IF PRINTED

    FOIL UNDER CAP IS BROKEN OR MISSING.

    30 TABLETS

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code GG296
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-112-441 in 1 CARTON06/01/201610/31/2020
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49348-112-131 in 1 CARTON06/01/201610/31/2020
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49348-112-011 in 1 CARTON06/01/201605/31/2019
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520906/01/201610/31/2020
    Labeler - Sunmark (177667227)
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