Childrens Loratadine Tablet, Chewable
FDA Label NDC 11673-310

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Childrens Loratadine (NDC 11673-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each chewable tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Target Corporation
Minneapolis, MN 55403

Active Ingredient (In Each Chewable Tablet)

Loratadine USP, 5 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

Otc - Do Not Use

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Otc - Stop Use

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

  • chew or crush tablets completely before swallowing.

    • adults and children 6 years and over

    chew 2 tablets daily; not more than 2 chewable tablets in 24 hours

    children 2 to under 6 years of age

    chew 1 tablet daily; not more than 1 chewable tablet in 24 hours

    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

Other Information

  • phenylketonurics: contains phenylalanine 1.25 mg per tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

aspartame, carmine, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

Call 1-800-910-6874

Principal Display Panel - 5 Mg Tablet Blister Pack Carton

NDC 11673-310-30

Compare to active ingredient in Children's Claritin ®Chewables*

Ages 2+ Years

dye-free

children's
allergy

loratadine chewable tablets USP, 5 mg
antihistamine

up&up

non-drowsy**
indoor and outdoor allergies
24-hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

    • **When taken as directed. See drug facts panel.

    30 CHEWABLE TABLETS

    THE CHEWABLE TABLETS ARE
    TO BE CHEWED BEFORE SWALLOWING

    GRAPE
    FLAVOR

    ACTUAL SIZE

    30
    CHEWABLE
    TABLETS

    30ct (Target Grape 30ct1)

    30ct (Target Grape 30ct1)

* Please review the disclaimer below.