Loratadine description, usages, side effects, indications, overdosage, supplying and lots more!

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Loratadine

Preferred Pharmaceuticals, Inc

Children's Loratadine Oral Solution


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Loratadine Oral Solution - Allergy

Active ingredient

Active Ingredient: Loratadine 5 mg (in each 5 mL)

Purpose

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 allergic reaction to this product or any of it's 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

2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours

children 2 to under 6 years of age

1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Loratadine Other information

  • Each teaspoonful contains: sodium 1 mg
  • •Safety Sealed. Do not use if imprinted seal around cap is broken or missing
  • •Store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

How Supplied

5 mg (in each 5 mL) - 68788-9805-1

Questions

1-888-974-5279

Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA
Revised – 11/10

Relabeled by Preferred Pharmaceuticals, Inc.


Loratadine

Loratadine SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68788-9805(NDC:0904-6234)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLATED HYDROXYANISOLE
GLYCERIN
propylene glycol
SODIUM BENZOATE
Sucralose
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68788-9805-1 120 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077421 2012-05-09


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Be sure to consult your doctor before taking any medication!
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