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 UP & UP, 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 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.

SPL UNCLASSIFIED SECTION

Distributed by Target Corporation
Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

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

NDC: 11673-111-30

dye-free
children's
allergy

loratadine chewable tablets USP, 5 mg
antihistamine

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.

up & up

GRAPE
FLAVOR

ACTUAL SIZE

30
CHEWABLE
TABLETS

30 CHEWABLE TABLETS

THE CHEWABLE TABLETS ARE
TO BE CHEWED BEFORE SWALLOWING

INGREDIENTS AND APPEARANCE

DYE-FREE CHILDRENS LORATADINE 
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-111
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: 11673-111-30	3 in 1 CARTON	11/17/2020
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	11/17/2020

Labeler - UP & UP (006961700)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(11673-111)