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Loratadine

Preferred Pharmaceuticals, Inc

Loratadine Tablets, 10 mg Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Loratadine Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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.

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

Loratadine Other information

  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Repackaged By:

Preferred Pharmaceuticals, Inc

Anaheim, CA

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.

Original Prescription Strength

Actual Size

Loratadine
Loratadine Tablets, 10 mg

Loratadine

Loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9080(NDC:45802-650)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
MAGNESIUM STEARATE
povidone
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm L612 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9080-3 30 in 1 BOTTLE, DISPENSING

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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