Loratadine by Blenheim Pharmacal, Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Blenheim Pharmacal, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
• 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 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 induction seal, with "Lift N Peel" tab, under cap is broken or missing
• store between 2° and 30°C (36° and 86°F)
• protect from exceesive moisture

Inactive ingredients

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

• Manufactured by: Manufactured for:
• Apotex Inc.: Apotex Corp.
• Toronto, Ontario: Weston, Florida
• Canada M9L 1T9: 33326

Revised: March 2005

Principal Display Panel

Loratadine Tablets, USP 10mg

30 Tablets

NDC: 10544-455-30

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10544-455(NDC:60505-0147)
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)
CELLULOSE, MICROCRYSTALLINE (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: 10544-455-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076471	02/09/2014

Labeler - Blenheim Pharmacal, Inc. (171434587)

Registrant - Blenheim Pharmacal, Inc. (171434587)

Establishment
Name	Address	ID/FEI	Business Operations
Blenheim Pharmacal, Inc.		171434587	repack(10544-455)