Loratadine
Lannett Company, Inc.
Human Otc Drug
NDC 54838-554Loratadine is a human otc drug labeled by 'Lannett Company, Inc.'. National Drug Code (NDC) number for Loratadine is 54838-554. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Loratadine drug includes Loratadine - 5 mg/5mL . The currest status of Loratadine drug is Active.
Drug Information:
| Drug NDC: | 54838-554 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Loratadine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Loratadine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lannett Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | LORATADINE - 5 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 24 Nov, 2010 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA077421 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Lannett Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 692783
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0354838552409
|
| UPC stands for Universal Product Code. |
| UNII: | 7AJO3BO7QN
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54838-554-40 | 120 mL in 1 CARTON (54838-554-40) | 24 Nov, 2010 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose: antihistamine
Purpose: antihistamine
Product Elements:
Loratadine loratadine loratadine loratadine anhydrous citric acid butylated hydroxyanisole glycerin propylene glycol sodium benzoate sucralose water grape flavor loratadine loratadine loratadine loratadine anhydrous citric acid butylated hydroxyanisole glycerin propylene glycol sodium benzoate sucralose water grape flavor
Indications and Usage:
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.
Warnings:
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 âanaphylaxisâ 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 wi
Read more...ll 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 donât 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.
Do Not Use:
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 âanaphylaxisâ 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 donât 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.
When Using:
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.
Dosage and Administration:
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)
Stop Use:
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 donât improve after 3 days of treatment the hives have lasted more than 6 weeks
Spl Patient Package Insert:
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 â hives relief original prescription strength â 24 hour product relief of itching due to hives (please read all of this information before taking loratadine oral solution â 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 â 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 ser
Read more...ious 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 â 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 â 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 â hives relief product? people who have hives (urticaria) and are 6 years of age or older can take loratadine oral solution â hives relief product. (see label directions for proper dose.) who should not take loratadine oral solution â 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 â hives relief product to prevent the hives from occurring? loratadine oral solution â 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 â 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 â hives relief product if you (or your child) have: a rash or itching that does not get better after taking loratadine oral solution â hives relief product for 3 days hives that keep coming back. how long can loratadine oral solution â hives relief product be taken to relieve the itching? loratadine oral solution â hives relief product can be taken during the entire time that you have itching due to hives (see directions). donât forget, if the hives last longer than 6 weeks, contact your doctor. how should loratadine oral solution â 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
Package Label Principal Display Panel:
Carton
Hives carton
Further Questions:
Questions 1-888-974-5279 distributed by: lannett company, inc. philadelphia, pa 19136
Questions 1-888-974-5279 manufactured by: silarx pharmaceuticals, inc. 1033 stoneleigh ave carmel, ny 10512 usa