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| Product NDC Code | 55154-4976 | ||||
|---|---|---|---|---|---|
| Drug Name | Loratadine |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 311372 | ||||
| Application Number | ANDA076134 | ||||
| Labeler Name | Cardinal Health 107, 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 Drug Facts Loratadine Tablets USP, 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 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 consumers with liver or kidney disease ask a doctor FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
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 Non-Drowsy* 24 Hour *When taken as directed. See Drug Facts Panel. Indoor and Outdoor Allergies Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing
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.Loratadine Loratadine LORATADINE LORATADINE STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE RX526
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 Non-Drowsy* 24 Hour Allergy Relief Loratadine Tablets, USP 10 mg Antihistamine 10 Tablets Bag Label
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 store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
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 (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Questions? for Ranbaxy/Ohm Laboratories call 1-800-406-7984 The drug product contained in this package is from NDC#51660-526, Ohm Laboratories Inc. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 americanhealthpackaging.com An AmerisourceBergen Company AMERICAN HEALTH PACKAGING is a trademark owned by its respective owner. Distributed by: Cardinal Health Dublin, OH 43017 L4955647-10124 L4955647-20124
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 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.
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. This package is intended for institutional use only. This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.
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