Drug Facts

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

Warnings

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

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

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

Stop use and ask a doctor ifan 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

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 68° to 77°F (20° to 25°C).

Inactive ingredients

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

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 56062-921-20

FOR AGES 2+ YEARS
INDOOR & OUTDOOR ALLERGIES

children'sallergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*
24-hour relief of:
• Sneezing • Runny nose
• Itchy, watery eyes • Itchy throat or nose

DYE FREE

ACTUAL
SIZE

20
CHEWABLE
TABLETS

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

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

grape--20

DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-921
Route of Administration	ORAL

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

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (bevelled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	LC5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:56062-921-20	2 in 1 CARTON	03/15/2024
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	03/15/2024

Labeler - PUBLIX SUPER MARKETS, INC (006922009)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	manufacture(56062-921)

Dye-Free Children's Loratadine Chewable Tablets USP, 5 mg