Dye-free Childrens Loratadine Tablet, Chewable
FDA Label NDC 11822-8329

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Dye-free Childrens Loratadine (NDC 11822-8329). 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 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:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011

Active Ingredient (In Each 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 use if 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 have liver or kidney disease. Your doctor should determine if you need a different dose.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if an 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 overchew 2 tablets daily; not more than 2 tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask 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, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Principal Display Panel - 5 Mg Tablet Blister Pack Carton

FREE
FROM
DYE FREE

24 HOUR

NDC 11822-8329-7

Compare to the active
ingredient of Children's
Claritin® Chewables**

AGES 2 YEARS & OLDER

CHILDREN'S
ALLERGY RELIEF

CHEWABLE TABLETS • ANTIHISTAMINE
DYE-FREE

LORATADINE CHEWABLE TABLETS USP, 5 mg
NON-DROWSY* INDOOR / OUTDOOR ALLERGIES
24 HOUR RELIEF OF
Sneezing • Runny nose • Itchy, watery eyes
Itchy throat or nose

ACTUAL SIZE

GRAPE
FLAVOR
30
CHEWABLE TABLETS

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING.

Principal Display Panel (5 mg Tablet Blister Pack Carton)

Principal Display Panel (5 mg Tablet Blister Pack Carton)

* Please review the disclaimer below.