LORATADINE- loratadine tablet
Kaiser Foundation Hospitals

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Drug Facts

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:

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 (1-800-222-1222).

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

store between 20° to 25° C (68° to 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

KAISER PERMANENTE ®

NDC 0179-8317-30

Loratadine Tablets, USP 10 mg

Antihistamine

Non-Drowsy* 24-hr allergy relief

for indoor and outdoor allergies

Relief of sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

†Compare to the active ingredient in Claritin ®

30 TABLETS

*When taken as directed. See Drug Facts Panel.

Distributed by: Kaiser Foundation Hospitals

5101871/0313

LORATADINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0179-8317
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	Marketing End Date
Packaging
1	NDC:0179-8317-30	1 in 1 CARTON	02/23/2011	08/31/2020
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0179-8317-01	1 in 1 CARTON	02/23/2011	08/31/2020
2		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	02/23/2011	08/31/2020

Labeler - Kaiser Foundation Hospitals (053052619)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(0179-8317)

Revised: 11/2018

Document Id: 7b098b92-2a83-569a-e053-2991aa0aae2d

Set id: 4ba788ce-d97e-442f-a6d6-c1843f86f4fe

Version: 2

Effective Time: 20181119

Kaiser Foundation Hospitals