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

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Childrens Loratadine

Aidarex Pharmaceuticals LLC

Childrens Loratadine


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 5 mg

Purpose

Antihistamine

Childrens 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.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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
 consumers with liver or kidney disease  ask a doctor

Childrens Loratadine Other information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 33261-908-01

Compare to the
active ingredient
in Claritin®*

GRAPE
FLAVOR

Original
Prescription Strength

Ages two years and older

Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Grape Flavored Syrup

24 hour
Non-Drowsy

Allergy Relief

Relief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

Childrens Loratadine

Childrens Loratadine

Loratadine SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33261-908(NDC:51672-2085)
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
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM BENZOATE
SODIUM METABISULFITE
SUCROSE

Product Characteristics

Color
YELLOW (colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-908-01 5 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076805 2004-08-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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