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(teaspoonful)(TSP))

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 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.

Directions

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

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

Loratadine Oral Solution - Hives Relief

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

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:

  • foods
  • insects stings
  • medicines
  • latex or rubber gloves

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

  • liver or kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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. Get medical help right away
  • symptoms don’t improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 (tsp) daily; do not take more than 2 teaspoonfuls (tsp) 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.
1033 Stoneleigh Ave
Carmel, NY 10512 USA

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?
Hives are itchy raised red or pink bumps, blotches or streaky areas of various sizes on the surface of the skin. They can come and go.

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?
Many things, including food, drugs (medicines), insect stings, stress, exercise or temperature can cause hives. A doctor may be able to help you find the cause of your hives. When you know the cause, avoid it.

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?
Hives can last from a few hours to a few weeks, and often come and go. See a doctor if your hives have lasted more than 6 weeks.

Are hives very serious?
Hives are very common and they are usually not serious. But in rare cases, they can be the first sign of a life threatening allergic reaction called anaphylaxis. A sign that you have this serious reaction would be that you have hives along with any of the following symptoms:

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.
If your doctor has prescribed an epinephrine injector for your severe allergic reactions, your doctor is concerned that your hives might lead to a severe allergic reaction (anaphylaxis) or to asthma-like symptoms that could occur with your hives. Loratadine Oral Solution – Hives Relief product is not a substitute for epinephrine. If you have been prescribed an epinephrine injector, carry it with you at all times.

Who can take Loratadine Oral Solution – Hives Relief Product?
People who have hives (urticaria) and are 6 years of age or older can take Loratadine Oral Solution – Hives Relief product. (See label Directions for proper dose.)

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?
Loratadine Oral Solution – Hives Relief product should never be used to prevent hives or allergic skin reactions from any known cause. Such causes can include but are not limited to:

If you have ever had an allergic reaction to any of these causes, you should see a doctor.

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

If you are pregnant or breast feeding, you should ask a doctor or health professional before use.

Contact a doctor while taking Loratadine Oral Solution – Hives Relief Product if you (or your child) have:

How long can Loratadine Oral Solution – Hives Relief product be taken to relieve the itching?
Loratadine Oral Solution – Hives Relief product can be taken during the entire time that you have itching due to hives (see Directions). Don’t forget, if the hives last longer than 6 weeks, contact your doctor.

How should Loratadine Oral Solution – Hives Relief product be taken?

What else can I do to make the itching and rash feel better?
Wear loose clothing to help reduce irritation. Keeping the temperature cool can help with the itching.

Other important information:

* When taken as directed. See drug facts panel on carton.

Silarx Pharmaceuticals, Inc.
Carmel, NY 10512
USA


Carton Label


Caton Label - Hives Relief



LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-558
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylated hydroxyanisole 
glycerin 
propylene glycol 
sodium benzoate 
sucralose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-558-40120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742111/24/2010
LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-554
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylated hydroxyanisole 
glycerin 
propylene glycol 
sodium benzoate 
sucralose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-554-40120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742111/24/2010
Labeler - Silarx Pharmaceuticals, Inc (078500185)

Revised: 1/2014
Document Id: d9c9ea9c-1f78-4478-9765-8d4d9ac73216
Set id: 069c4e75-1f9f-4ab5-9570-3d93d12c2a23
Version: 11
Effective Time: 20140114
 
Silarx Pharmaceuticals, Inc