Leader Childrens Allergy Relief description, usages, side effects, indications, overdosage, supplying and lots more!

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Leader Childrens Allergy Relief

Cardinal Health

Leader Children's Allergy Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Leader Childrens Allergy Relief 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. (1-800-222-1222)

Directions

  • use only with enclosed dosing cup
adults and children 6 years and over 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Leader Childrens Allergy Relief Other information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68°and 77°F)

Inactive ingredients

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

Questions?

Call 1-800-200-6313

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

LEADER ®

NDC 37205-570-26

Compare to
Children's Claritin®

active ingredient

Original Prescription
Strength

NON-DROWSY*

CHILDREN'S
Allergy
Relief

Loratadine Syrup
(Loratadine Oral Solution) 5 mg/5 mL

Antihistamine

24 Hour

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

Indoor & Outdoor
Allergies

Grape Flavor

*When taken as directed.
See Drug Facts Panel.

Ages two years
and older

SATISFACTION
GUARANTEED

4 FL OZ (120 mL)

Leader Childrens Allergy Relief

Leader Childrens Allergy Relief

Loratadine SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-570
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:37205-570-26 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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