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| Product NDC Code | 68788-7291 | ||||
|---|---|---|---|---|---|
| Drug Name | Loratadine |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 692783 | ||||
| Application Number | ANDA077421 | ||||
| Labeler Name | Preferred Pharmaceuticals Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))
Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful(tsp)))
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
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)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
Inactive ingredients Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Uses • relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Purpose
Information about the drug product’s indications for use.Purpose: Antihistamine
Purpose: Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Loratadine Loratadine LORATADINE LORATADINE ANHYDROUS CITRIC ACID BUTYLATED HYDROXYANISOLE GLYCERIN PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE WATER grape flavor
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Loratadine Solution 5mg/5mL
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Loratadine Oral Solution - Allergy
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)
Loratadine Oral Solution - Hives Relief
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. 1033 Stoneleigh Ave. Carmel, NY 10512 10-1108 Rev. 11/17 Relabeled By: Preferred Pharmaceuticals Inc.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512 USA
Questions 1-888-974-5279 Manufactured by: Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave Carmel, NY 10512 Relabeled By: Preferred Pharmaceuticals Inc.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not take more than directed. Taking more than directed may cause drowsiness.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
If pregnant or breast-feeding , ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API