Loratadine by Major Pharmaceuticals / Ranbaxy Pharmaceuticals Inc. / Ohm Laboratories Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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®.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6074
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 (White to Off White)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/28/2003	11/13/2021

Labeler - Major Pharmaceuticals (191427277)