NDC 17856-0557 Loratadine

Loratadine

NDC Product Code 17856-0557

NDC Code: 17856-0557

Proprietary Name: Loratadine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Loratadine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 17856 - Atlantic Biologicals Corp.
    • 17856-0557 - Loratadine

NDC 17856-0557-1

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 5 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Loratadine with NDC 17856-0557 is a a human over the counter drug product labeled by Atlantic Biologicals Corp.. The generic name of Loratadine is loratadine. The product's dosage form is solution and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Loratadine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LORATADINE 5 mg/5mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Atlantic Biologicals Corp.
Labeler Code: 17856
FDA Application Number: ANDA077421 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-13-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Loratadine Product Label Images

Loratadine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat

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

Warnings

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

  • Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:trouble swallowingdizziness or loss of consciousnessswelling of tongueswelling in or around mouthtrouble speakingdroolingwheezing or problems breathingThese 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.

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

  • 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 doctorOther informationSafety sealed. Do not use if imprinted seal around cap is broken or missingStore between 20° to 25°C (68° to 77°F)

Other Information

  • Each teaspoonful contains: sodium 1 mgSafety Sealed. Do not use if imprinted seal around cap is broken or missingStore between 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

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

Questions

DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.MIAMI, FL 33179

DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.MIAMI, FL 33179

Do Not Use

  • - to prevent hives from any known cause such as:foods insects stingsmedicineslatex or rubber glovesbecause 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

Patient Leaflet

  • Once Daily / Non-Drowsy*Loratadine Oral SolutionHives Relief5 mg per 5 mLAntihistamineWhat you should know about:Non- Drowsy*Loratadine Oral Solution – Hives ReliefOriginal Prescription Strength – 24 Hour ProductRelief 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 DroolingHives AND any of these symptoms means call 911 or Get Immediate Medical HelpCan 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 weeksIf 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.

* Please review the disclaimer below.

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