LORATADINE by Major Pharmaceuticals LORATADINE tablet

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. 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:

• 1. runny nose
• 2. sneezing
• 3. itchy, watery eyes
• 4. 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

• 1. store between 2° and 30°C (36° and 86°F)
• 2. protect from excessive moisture
• 3. This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments? 

Call (800) 616-2471

Generic Section

Distributed by:

Distributed By:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MADE IN CANADA

Principal Display Panel

Loratadine Tablets, USP

10 mg

100 Tablets

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5793(NDC:0536-1092)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	LOR;10;APO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5793-61	100 in 1 CARTON	06/22/2016	06/30/2020
1		1 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	ANDA076471	06/22/2016	06/30/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)