Loratadineantihistamineantihistamine tablet

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 25C (68 to 77F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Loratadineantihistamineantihistamine tablet- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49349-218
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)
Povidones ( UNII: FZ989GH94E)

Product Characteristics

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

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-218-02 30 in 1 BLISTER PACK 2011/01/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076301 USA 2011/01/12

Labeler - REMEDYREPACK INC.( 829572556)

Package label.principal display panel

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-218-02

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POVIDONES