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| Product NDC Code | 70264-030 | ||||
|---|---|---|---|---|---|
| Drug Name | Claritin |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 206805, 311372 |
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| Application Number | NDA019658 | ||||
| Labeler Name | R J General Corporation | ||||
| 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.CLARITIN ® Active ingredients (in each tablet) Purpose Loratadine 10 mg Antihistamine
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Coen starch, lactose monohydrate, magnesium stearate
Spl product data elements
Usually a list of ingredients in a drug product.Claritin Loratadine LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN LORATADINE LORATADINE 458;Claritin;10
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 - 25 Tablet Pouch Carton Non-Drowsy* Claritin ® loratadine tablets 10 mg/ antihistamine Indoor & Outdoor Allergies Relief of: runny nose itchy, watery eyes sneezing itching of the throat or nose image description
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.USE 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
Directions adults and children 6 years and over 1 tablet daily: not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumer with liver or kidney disease ask a doctor
Other information Safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn Store between 20 o to 25 o C (68 o to 77 o F) Protect from excessive moisture
Questions and Comments? 1-800-CLARITIN(1-800-252-7484) or www.claritin.com Dist. by: Bayer HealthCare LLC Whippany, NJ 07981 Product of Ireland Do not use if pouch is torn or broken. Repackaged and distributed by: RJ General 2024 Northwest Drive Cincinnati OH 45231
| adults and children 6 years and over | 1 tablet daily: not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumer with liver or kidney disease | ask a doctor |
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 don not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask 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