Active ingredient (in each tablet)

Loratadine 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

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch, glycolate.

call toll-free 1-800-935-6737

PDP

DF1

DF2

ALLERGY RELIEF 10 MG
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55681-303-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210722	03/02/2022

Labeler - TWIN MED LLC (009579330)