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Major Pharmaceuticals

Major Pharmaceuticals Allergy Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

allergy 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

allergy Other information

  • do not use if blister unit is broken or torn {Blister Only}
  • do not use if printed foil under cap is broken or missing {Bottle Only}
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture {Blister Only}

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the active ingredient of CLARITIN®

Original Prescription Strength

Non-Drowsy*

Allergy

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

Actual Size

24 HOUR

Relief of:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

allergy
Allergy Carton Image 1 Allergy Carton Image 2

allergy

Loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5728
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

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm L612 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 90 in 1 BOTTLE
2 10 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 NDC:0904-5728-15 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076301 2005-02-21


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Be sure to consult your doctor before taking any medication!
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