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Loratadine

Cardinal Health

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Original Prescription Strength
Non-Drowsy

Indoor and Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Active ingredient (in each tablet)

Loratadine USP, 10 mg

Purpose

Antihistamine

Loratadine 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.

Directions (24 Hour Relief)

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

  • TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Questions or comments?

1-800-848-0462

  • Serious side effects associated with use of this product may be reported to this number.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-10314 R1
7/11

Principal Display Panel

Loratadine Tablets, USP

10 mg

Antihistamine

10 Tablets

Loratadine

Loratadine

loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-5099(NDC:51079-538)
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONES
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 7 mm M;L;17 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-5099-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075790 2009-11-19


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Be sure to consult your doctor before taking any medication!
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