LORATADINE- loratadine tablet
Major Pharmaceuticals

----------

Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine USP, 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

•: store between 20 and 25° C (68 and 77° F)
•: protect from excessive moisture
•: TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

LIVONIA, MI 48150 USA

PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6074-15

Non-Drowsy*

Original Prescription Strength

Allergy

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 HOUR

10 Tablets

Relief of:

Sneezing; Runny Nose;

Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

Compare to the active ingredient of Claritin®†

†This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin®.

This is the blister carton label for 10 count Loratadine tablets USP, 10 mg.

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6074
Route of Administration	ORAL

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

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

Product Characteristics
Color	WHITE (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0904-6074-46	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2003	11/13/2021
2	NDC:0904-6074-60	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2003	12/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	08/28/2003	11/13/2021

Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020

Document Id: 5eb28212-b4cd-4e34-8d32-83b8e4055d08

Set id: d18dfc27-5e0e-4030-b0f3-f49bb25b6869

Version: 3

Effective Time: 20200129

Major Pharmaceuticals