DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable

DYE-FREE CHILDRENS LORATADINE by

Drug Labeling and Warnings

DYE-FREE CHILDRENS LORATADINE by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPER MARKETS, INC, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

• chew or crush tablets completely before swallowing.

• adults and children 6 years and over: chew 2 tablets daily; not more than 2 tablets in 24 hours
• children 2 to under 6 years of age: chew 1 tablet daily; not more than 1 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC: 56062-900-20

FOR AGES 2 YEARS AND OLDER
INDOOR & OUTDOOR ALLERGIES

children's allergy

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

INGREDIENTS AND APPEARANCE

DYE-FREE CHILDRENS LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-900
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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	106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-900-20	2 in 1 CARTON	09/01/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210088	09/01/2020

Labeler - PUBLIX SUPER MARKETS, INC (006922009)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(56062-900)