CLARITIN- loratadine tablet

Claritin by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Loratadine, 10 mg USP

PURPOSE

Purpose

Antihistamine

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

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

Ask a doctor

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

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

Stop use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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

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

■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)

INACTIVE INGREDIENT

Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

QUESTIONS

Questions or comments?

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

Carton label 10 count tablets

Original Prescription Strength

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

Indoor & Outdoor

Allergies

24

Hour

Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel

INGREDIENTS AND APPEARANCE

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0800
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Claritin;10;458
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0800-1	1 in 1 CARTON	03/16/2022
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11523-0800-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075209	12/01/2020

Labeler - Bayer HealthCare LLC. (112117283)