Perrigo Loratadine Tablets, 10 mg Drug Facts

OTC - ACTIVE INGREDIENT

Loratadine 10 mg

OTC - PURPOSE

Antihistamine

INDICATIONS & USAGE

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

if you have ever had an allergic reaction to this product or any of its ingredients

liver or kidney disease. Your doctor should determine if you need a different dose.

do not take more than directed. Taking more than directed may cause drowsiness.

an allergic reaction to this product occurs. Seek medical help right away.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

•do not use if printed foil under cap is broken or missing•store between 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

OTC - QUESTIONS

1-800-719-9260

OTC - KEEP OUT OF REACH OF CHILDREN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-600-14

ACTIVE INGREDIENT(S):

LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONES

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 2 in 1 BOTTLE

MM1

MM2

LORATADINEANTIHISTAMINE ANTIHISTAMINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52125-600(NDC:45802-650)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONES (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (TABLET)	Size	8mm
Flavor		Imprint Code	L612
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52125-600-14	2 in 1 BOTTLE; Type 0: Not a Combination Product	04/02/2015	07/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076301	04/02/2015	07/11/2016

Labeler - REMEDYREPACK INC. (829572556)

Revised: 7/2016

Document Id: 375beaeb-34bd-448d-e054-00144ff8d46c

Set id: 5ff31815-44b8-4d3d-92b2-541bc49b5283

Version: 2

Effective Time: 20160711

REMEDYREPACK INC.