Loratadine by A-S Medication Solutions LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. 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°C and 30°C (36°F and 86°F)
• protect from excessive moisture

Inactive ingredients

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

HOW SUPPLIED

Product: 50090-0838

NDC: 50090-0838-0 10 TABLET in a BOTTLE

NDC: 50090-0838-1 20 TABLET in a BOTTLE

NDC: 50090-0838-3 15 TABLET in a BOTTLE

NDC: 50090-0838-4 30 TABLET in a BOTTLE

NDC: 50090-0838-5 90 TABLET in a BOTTLE

NDC: 50090-0838-6 7 TABLET in a BOTTLE

Questions or comments?

Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time

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

Revised: August 2018

Loratadine

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-0838(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)
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: 50090-0838-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
2	NDC: 50090-0838-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
3	NDC: 50090-0838-3	15 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
4	NDC: 50090-0838-6	7 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
5	NDC: 50090-0838-0	10 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014
6	NDC: 50090-0838-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076471	01/24/2005

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-0838) , REPACK(50090-0838)