Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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).

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

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.

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

call 1-800-406-7984

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Loratadine 10 mg Tablet

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

Loratadine 10 mg Tablet

LORATADINE ALLERGY RELIEF
loratadine tablet

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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63629-7772-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2018
2	NDC:63629-7772-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2018
3	NDC:63629-7772-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2019
4	NDC:63629-7772-4	14 in 1 BOTTLE; Type 0: Not a Combination Product	12/11/2018
5	NDC:63629-7772-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2018
6	NDC:63629-7772-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/05/2018
7	NDC:63629-7772-7	28 in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2024
8	NDC:63629-7772-8	15 in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2024
9	NDC:63629-7772-9	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/21/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	11/01/2017

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-7772) , RELABEL(63629-7772)