CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 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.

Directions

adults and children 6 years and over 1 tablet daily; not more

than 1 tablet in 24 hours

children under 6 years of age ask a doctor

consumers with liver

or kidney disease ask a doctor

Other Information

● safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn

● store between 20° to 25°C (68° to 77°F)

● protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or Comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Package Label

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73097-005(NDC:11523-7160)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73097-005-01	1 in 1 CARTON	07/03/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-005-20	20 in 1 CARTON	07/03/2019
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73097-005-25	25 in 1 CARTON	07/03/2019
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019658	07/03/2019

Labeler - Savings Distributors LLC (010527359)