LORATADINE  - loratadine solution 
Silarx Pharmaceuticals, Inc

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Children's Loratadine Oral Solution

Loratadine Oral Solution - Allergy

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

Purpose: Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

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

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
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

Inactive ingredients

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

Questions

1-888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977 USA
Revised – August 2010

Loratadine Oral Solution - Hives Relief

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

Purpose: Antihistamine

Uses

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

- to prevent hives from any known cause such as:

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

- if you have ever had an allergic reaction to this product (loratadine) or any of its ingredients

Ask a doctor before use if you have

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

Stop use and ask a doctor if

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 under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
Other information

Inactive ingredients

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

Questions

1-888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977 USA
Revised – August 2010

Patient Leaflet

Once Daily / Non-Drowsy*
Loratadine Oral Solution
Hives Relief
5 mg per 5 mL
Antihistamine

What you should know about:
Non- Drowsy*
Loratadine Oral Solution – Hives Relief
Original Prescription Strength – 24 Hour Product

Relief of Itching Due to Hives
(Please read all of this information before taking Loratadine Oral Solution – Hives Relief Product. Save this leaflet for future reference.)

What is Loratadine Oral Solution - Hives Relief product?

Loratadine Oral Solution - Hives Relief product contain loratadine, a non-drowsy *antihistamine.

Loratadine Oral Solution – Hives Relief
Original prescription strength medicine to relieve itching due to hives.
What are hives and what do they look like?


Do not use this product if your hives look bruised, have an unusual color, or look blistered. These may be signs of a more serious problem. If you have these signs, ask a Doctor before taking Loratadine Oral Solution -Hives Relief product.

What can cause hives?


Do not use this product to prevent hives or allergic skin reactions known to be caused by food, insect stings, medicines, latex or rubber gloves, or any other causes. Many medicines can cause hives.

How long do hives last?


Are hives very serious?
But in rare cases, they can be the first sign of a life threatening allergic reaction
Hives AND any of these symptoms means call 911 or Get Immediate Medical Help

Can I use Loratadine Oral Solution -Hives Relief product instead of an epinephrine injection for my allergic reaction?

Never use Loratadine Oral Solution – Hives Relief product as a substitute for epinephrine.


Who can take Loratadine Oral Solution – Hives Relief Product?


Who should not take Loratadine Oral Solution – Hives Relief Product?
What if I know the cause of my hives and I want to take Loratadine Oral Solution – Hives Relief Product to prevent the hives from occurring?



When should you contact a doctor?
Contact a doctor before taking Loratadine Oral Solution – Hives Relief



Contact a doctor while taking Loratadine Oral Solution – Hives Relief Product
How long can Loratadine Oral Solution – Hives Relief product be taken to relieve the itching?


How should Loratadine Oral Solution – Hives Relief product be taken?
What else can I do to make the itching and rash feel better?


Other important information:






Carton Label

Container Label


Caton Label - Hives Relief


Container Label - Hives Relief



LORATADINE 
loratadine   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-558
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (Loratadine) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
butylated hydroxyanisole  
glycerin  
propylene glycol  
sodium benzoate  
sucralose  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-558-40 120 mL In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077421 11/24/2010

LORATADINE 
loratadine   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-554
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (Loratadine) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
butylated hydroxyanisole  
glycerin  
propylene glycol  
sodium benzoate  
sucralose  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-554-40 120 mL In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077421 11/24/2010

Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 12/2010 Silarx Pharmaceuticals, Inc