ACTIVE INGREDIENT(S)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USE(S)

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 and 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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PDP

LORATADINE ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-3208(NDC:51660-526)
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
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68071-3208-1	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
2	NDC:68071-3208-4	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
3	NDC:68071-3208-7	7 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
4	NDC:68071-3208-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
5	NDC:68071-3208-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
6	NDC:68071-3208-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017
7	NDC:68071-3208-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	08/28/2003

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals, Inc.		010632300	repack(68071-3208)

Drug Facts