CURIST CHILDRENS ALLERGY RELIEF- loratadine 5 mg chewable tablets tablet, chewable

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Loratadine USP, 5 mg
PURPOSE

Purpose

Antihistamine
INDICATIONS & USAGE
Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
WARNINGS

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).

DOSAGE & ADMINISTRATION

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 tablets in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

STORAGE AND HANDLING
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 20º to 25ºC (68º to 77ºF).
INACTIVE INGREDIENT

Inactive ingredients

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

Questions? Call 1-844-243-1241 or email hi@curistrelief.com
SPL UNCLASSIFIED SECTION

Keep the carton. It contains important information. See end panel for expiration date.
SPL UNCLASSIFIED SECTION

REV: 031-43-01

NDC: 72559-031-43

Distributed by: Little Pharma, Inc.

New York, NY 10023

Tableted and Packaged in USA
PRINCIPAL DISPLAY PANEL

curist kids

Children's Allergy Relief

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of Sneezing;

Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose

Non-Drowsy*

60 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

AGES 2+ YEARS

*When taken as directed. See Drug Facts Panel.

Grape Flavored

Dye-Free

curistrelief.com

INGREDIENTS AND APPEARANCE

CURIST CHILDRENS ALLERGY RELIEF
loratadine 5 mg chewable tablets tablet, chewable

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72559-031-43	6 in 1 CARTON	06/12/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210088	06/12/2024

Labeler - Little Pharma, Inc. (074328189)

Curist Childrens Allergy Relief by