Loratadine by Cardinal Health LORATADINE solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

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

Other information

• do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
• see bottom panel for lot number and expiration date
• store between 20° and 25°C (68° and 77°F)

Inactive ingredients

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

Questions?

Call 1-866-923-4914

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DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

LEADER™

Non-Drowsy†
Children's
Allergy

Loratadine Oral Solution
USP, 5 mg/5 mL

Antihistamine Allergy
Indoor & Outdoor Allergies

Fruit Flavor
Dye Free

24 Hour
Relief of:

• Sneezing
• Runny Nose
• Itchy Watery Eyes
• Itchy Throat or Nose

Ages 2 Years
and Older

COMPARE TO
CHILDREN'S
CLARITIN®
active ingredient*

100% Money
Back Guarantee

†When taken as directed. See Drug Facts Panel.

WARNING: Contains sodium metabisulfite, a sulfite that
may cause allergic-type reactions.

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN)	Loratadine	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium metabisulfite (UNII: 4VON5FNS3C)
sucrose (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0125-1	1 in 1 CARTON	10/24/2016
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Cardinal Health (097537435)