Loratadine tablet

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 IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

Call 1-800-406-7984

Ingredients and appearance - Product information

Loratadine tablet- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0179-8317
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color white (White to Off-White) Shape ROUND
Size 6 mm Score 1
Imprint Code RX526

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076134 USA

Labeler - Kaiser Foundation Hospitals( 053052619)

Establishment

Name ID/FEI Business Operations
Kaiser Foundation Hospitals 053052619 manufacture( 0179-8317)

Principal display panel

KAISER PERMANENTE ®

NDC 0179-8317-30

Loratadine Tablets, USP 10 mg

Antihistamine

Non-Drowsy* 24-hr allergy relief

for indoor and outdoor allergies

Relief of sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

Compare to the active ingredient in Claritin ®

30 TABLETS

* When taken as directed. See Drug Facts Panel.

Distributed by: Kaiser Foundation Hospitals

5101871/0313