Children's Loratadine Oral Solution

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use if you have ever had allergic reaction to this product or any of it's ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

• 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

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

1-800-616-2471

Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• Loratadine
• anhydrous citric acid
• butylated hydroxyanisole
• glycerin
• propylene glycol
• sodium benzoate
• sucralose
• water

NDC Codes#

Ingredients#

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Source Document#

Source XML

Inactive ingredient matches#

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Orange Book products#

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Observed Orange Book product history#

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Product history page 1 of 2 · 44 observed states.

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Reported adverse events (FAERS/openFDA)#

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