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

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Childrens Loratadine

Rite Aid Corporation
Taro Pharmaceuticals U.S.A., Inc

Children's Loratadine Syrup


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
  • 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.
  • 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
RITE AID
CORPORATION
HARRISBURG,
PA 17105

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

RITE
AID
PHARMACY

Compare to active ingredient
in Children's Claritin®

Original
Prescription
Strength

Children's

Loratadine
Syrup

(Loratadine
Oral Solution)
5 mg/5mL Antihistamine

Grape Flavored Syrup
Ages 2 years and older

24-Hour Allergy Relief
Non-Drowsy*

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:11822-0850
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
1 120 in 1 BOTTLE
2 NDC:11822-0850-8 1 in 1 CARTON

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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