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 BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

Compare to Claritin® active ingredient†

NDC 37808-529-31

H-E-B®

Allergy Relief

Loratadine Tablets, USP 10 mg
Antihistamine

Non-Drowsy* Allergy Relief

Indoor & Outdoor Allergies

24
Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 TABLETS
*When taken as directed. See Drug Facts Panel.

actual
size

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

LORATADINE ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-529
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:37808-529-11	1 in 1 CARTON	02/01/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:37808-529-31	30 in 1 CARTON	02/01/2018
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:37808-529-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	02/01/2018

Labeler - HEB (007924756)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(37808-529)

Loratadine Allergy Relief