Active ingredient

Loratadine 10mg

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. You may report side effects to 1-888-952-0050.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and children 6 years and over: 1 tablet daily. No 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
do not use if imprinted seal under safety cap is brokenor missing [for bottle]
do not use if blister unit is torn or open [for blister]

Inactive ingredients

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

Principal Display Panel

Allergy Relief

ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-309
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
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	6mm
Flavor		Imprint Code	LOR10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69168-309-08	1 in 1 CARTON	12/16/2014
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69168-309-09	1 in 1 CARTON	12/16/2014
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:69168-309-30	1 in 1 CARTON	12/16/2014
3		30 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:69168-309-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2014
5	NDC:69168-309-03	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/16/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076471	12/16/2014

Labeler - Allegiant Health (079501930)

309 - Health A2Z Allergy Relief