Loratadine tablet

Uses

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

  • runny nosesneezing
  • itchy, watery eyes
  • itching of the nose or throat

Active ingredient in each tablet

Loratadine 10 mg

Purpose

Antihistamine

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.

Dosage & administration section


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 at 20-25C (68-77F)

Questions or comments?

1-800-719-9260

Inactive ingredients

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Keep out of reach of children

Ingredients and appearance - Product information

Loratadine tablet- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 61919-142
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
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidone ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color white Shape OVAL
Size 8 mm Score 1
Imprint Code L612

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076301 USA

Labeler - DIRECT RX( 079254320)

Establishment

Name ID/FEI Business Operations
DIRECT RX 079254320 repack( 61919-142), relabel( 61919-142)

Principal display panel

Compare to Claritin® active ingredient

Loratadine Tablets, 10 mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

10mg Label Image: