Label: LORATADINE - loratadine solution 

  • Label RSS
  • NDC Code(s): 54838-554-40, 54838-558-40
  • Packager: Silarx Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/14

If you are a consumer or patient please visit this version.

  • Loratadine Oral Solution - Allergy
  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Purpose: Antihistamine

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  • 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
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  • 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.

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  • 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
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  • Other information

    • 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)
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  • Inactive ingredients

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

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  • Questions

    1-888-974-5279

    Manufactured by:
    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512 USA

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  • Loratadine Oral Solution - Hives Relief
  • ACTIVE INGREDIENT

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

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  • PURPOSE

    Purpose: Antihistamine

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  • Uses

    • relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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  • Warnings

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

    • trouble swallowing
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    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.

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  • 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
    • Safety sealed. Do not use if imprinted seal around cap is broken or missing
    • Store between 20° to 25°C (68° to 77°F)
    Close
  • Inactive ingredients

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

    Close
  • Questions

    1-888-974-5279

    Manufactured by:
    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512 USA

    Close
  • 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:

    • Dizziness or feeling faint
    • Trouble swallowing
    • Wheezing or problems breathing
    • Trouble speaking
    • Hives or swelling in or around the mouth
    • Drooling

    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?

    • People who have ever had an allergic reaction to these products or any of their ingredients.
    • People who are taking any other products containing loratadine
    • People with liver or kidney disease unless directed by a doctor
    • Children under the age of 6 years.

    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:

    • Food
    • Insect Stings
    • Medicines
    • Latex or rubber gloves.

    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:

    • Hives that have an unusual color or that look bruised or blistered
    • Hives that have lasted longer than 6 weeks

    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:

    • A rash or itching that does not get better after taking Loratadine Oral Solution – Hives Relief product for 3 days
    • Hives that keep coming back.

    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?

    • Adults and children 6 years and older should take 2 teaspoonfuls of Loratadine Oral Solution (10 mg) daily.
    • Do not take more than one dose in 24 hour period.
    • If you have liver or kidney disease, ask a doctor.

    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:

    • Allergy Alert: Do not use if you are allergic to loratadine, any of its ingredients, or other antihistamines.
    • If you have been prescribed an epinephrine injector, you should carry it with you at all times.
    • Keep out of reach of children.
    • In case of an overdose, get medical help or contact a Poison Control Center right away.

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

    Silarx Pharmaceuticals, Inc.
    Carmel, NY 10512
    USA

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: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
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-558-40 120 mL in 1 CARTON
    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 LABEL Item Code (Source) NDC: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
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-554-40 120 mL in 1 CARTON
    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)
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