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| Product NDC Code | 0573-2620 | ||||||||||
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| Drug Name | Alavert allergy |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, ORALLY DISINTEGRATING | ||||||||||
| RxCUI drug identifier | 311373, 351855 |
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| Application Number | NDA021375 | ||||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||||
| 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 (IN EACH TABLET) Loratadine 10 mg
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 tablet melts in mouth. Can be taken with or without water. Age Dose adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Alavert Allergy Fresh Mint anhydrous citric acid, aspartame, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate Alavert Allergy Citrus Burst anhydrous citric acid, aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, crospovidone, dextrin, ferric oxides, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate
Alavert Allergy Fresh Mint anhydrous citric acid, aspartame, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate
Alavert Allergy Citrus Burst anhydrous citric acid, aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, crospovidone, dextrin, ferric oxides, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate
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 sneezing itchy, watery eyes itching of the nose or throat
Purpose
Information about the drug product’s indications for use.PURPOSE Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.ALAVERT ALLERGY loratadine ANHYDROUS CITRIC ACID ASPARTAME MICROCRYSTALLINE CELLULOSE CORN SYRUP MAGNESIUM STEARATE MANNITOL SILICON DIOXIDE SODIUM BICARBONATE LORATADINE LORATADINE off white beveled tablet A;24 ALAVERT ALLERGY loratadine ANHYDROUS CITRIC ACID ASPARTAME BUTYLATED HYDROXYANISOLE MICROCRYSTALLINE CELLULOSE CORN SYRUP CROSPOVIDONE (120 .MU.M) ICODEXTRIN FERRIC OXIDE RED MAGNESIUM STEARATE MALTODEXTRIN MANNITOL SILICON DIOXIDE SODIUM BICARBONATE LORATADINE LORATADINE an orange flat faced tablet beveled tablet A;24 orange mint
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.PRINCIPAL DISPLAY PANEL The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. ALAVERT allergy Fresh Mint Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine 18 Orally Disintegrating Tablets TASTES GREAT! Melts in your Mouth! Non-Drowsy* Allergy Relief *When taken as directed. See Drug Facts Panel. 24 HOUR Relief of Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat Compare to Claritin † & SAVE! † Claritin is a registered trademark of Schering Corporation Alavert Allergy Fresh Mint Packaging
PRINCIPAL DISPLAY PANEL ALAVERT allergy Citrus Burst Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine 18 Orally Disintegrating Tablets TASTES GREAT! Melts in your Mouth! Non-Drowsy* Allergy Relief *When taken as directed. See Drug Facts Panel. 24 HOUR Relief of Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat Compare to Claritin† & SAVE! †Claritin is a registered trademark of Schering Corporation Alavert Allergy Citrus Burst Packaging
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.OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet store at 20-25ºC (68-77ºF) keep in a dry place
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.
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 if you have ever had an allergic reaction to this product 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS? call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)
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.
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 use more than directed. Taking more than recommended may cause drowsiness.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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 an allergic reaction to this product 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. When using this product do not use more than directed. Taking more than recommended 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.
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