Loratadine Antihistamine

LORATADINE ANTIHISTAMINE- loratadine tablet
Bryant Ranch Prepack

Active ingredient (in each tablet)

Loratadine 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

•

do not use if printed foil under cap is broken or missing

•

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

HOW SUPPLIED

NDC: 63629-1329-1: 20 Tablets in a BOTTLE

NDC: 63629-1329-2: 30 Tablets in a BOTTLE

NDC: 63629-1329-3: 60 Tablets in a BOTTLE

NDC: 63629-1329-4: 14 Tablets in a BOTTLE

NDC: 63629-1329-5: 10 Tablets in a BOTTLE

NDC: 63629-1329-6: 90 Tablets in a BOTTLE

NDC: 63629-1329-7: 28 Tablets in a BOTTLE

NDC: 63629-1329-8: 15 Tablets in a BOTTLE

NDC: 63629-1329-9: 100 Tablets in a BOTTLE

Loratadine 10mg Tablet

LORATADINE ANTIHISTAMINE loratadine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-1329(NDC:45802-650) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED

Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63629-1329-1 20 TABLET in 1 BOTTLE None 2 NDC:63629-1329-2 30 TABLET in 1 BOTTLE None 3 NDC:63629-1329-3 60 TABLET in 1 BOTTLE None 4 NDC:63629-1329-4 14 TABLET in 1 BOTTLE None 5 NDC:63629-1329-5 10 TABLET in 1 BOTTLE None 6 NDC:63629-1329-6 90 TABLET in 1 BOTTLE None 7 NDC:63629-1329-7 28 TABLET in 1 BOTTLE None 8 NDC:63629-1329-8 15 TABLET in 1 BOTTLE None 9 NDC:63629-1329-9 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 10/15/2008

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK (63629-1329), RELABEL (63629-1329)

Revised: 02/2022 Bryant Ranch Prepack