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Product NDC Code | 58602-818 | ||||||||||||
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Drug Name | Loratadine |
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Type | Generic | ||||||||||||
Active Ingredients |
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Route | ORAL | ||||||||||||
Dosage Form | CAPSULE, LIQUID FILLED | ||||||||||||
RxCUI drug identifier | 828269 | ||||||||||||
Application Number | ANDA211900 | ||||||||||||
Labeler Name | Aurohealth LLC | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each capsule) Loratadine 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 capsule daily; not more than 1 capsule in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
adults and children 6 years and over | 1 capsule daily; not more than 1 capsule in 24 hours |
children under 6 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.
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.Loratadine Loratadine LORATADINE LORATADINE GELATIN TYPE B BOVINE (160 BLOOM) GLYCERIN GLYCERYL MONO- AND DICAPRYLOCAPRATE HYPROMELLOSE 2910 (3 MPA.S) ISOPROPYL ALCOHOL FD&C BLUE NO. 1 POLYSORBATE 80 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE LR10
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton) AUROHEALTH NDC 58602-818-83 Compare to the active ingredient in Claritin ® Liqui-Gels ®† Non-Drowsy * Loratadine Capsules USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 24 HOUR 10 Liquid-Filled Capsules *When taken as directed. See Drug Facts Panel. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)
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.
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 (1-800-222-1222) 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 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not use if the individual blister unit is open or torn store between 20° to 25°C (68° to 77°F) protect from freezing FDA approved dissolution test specifications differ from USP
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.
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