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| Product NDC Code | 59556-882 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ANDA211926 | ||||||
| Labeler Name | Strides Pharma Inc | ||||||
| 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 capsule) 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 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 FD & C Blue 1, Gelatin, Glycerin, Glyceryl Monocaprylocaprate, Isopropyl alcohol, Medium chain triglyceride, Polysorbate 80, Povidone K-30, Purified Water, Soya Lecithin, Sorbitol Solution, Printing ink white-edible oil-Dewaxed Bleached Shellac Resins, Propylene Glycol, Sodium Lauryl Sulphate, 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 itchy, watery eyes sneezing 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 FD&C BLUE NO. 1 GELATIN GLYCERIN GLYCERYL CAPRYLATE/CAPRATE ISOPROPYL ALCOHOL LECITHIN, SOYBEAN MEDIUM-CHAIN TRIGLYCERIDES NONCRYSTALLIZING SORBITOL SOLUTION POLYSORBATE 80 POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TITANIUM DIOXIDE 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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL carton-label-10s
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.OTC - ASK DOCTOR 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.OTC - DO NOT USE 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.OTC - KEEP OUT OF REACH OF CHILDREN 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? Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com Manufactured by: Strides Pharma Science Limited Bengaluru – 562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 01/2020
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.OTC - STOP USE 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.OTC - WHEN USING When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Pregnancy or breast feeding
Pregnancy or Breast feedingOTC - PREGNANCY OR BREAST FEEDING If 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 safety sealed: do not use if the individual blister unit imprinted with Loratadine capsule is open or torn store between 20° to 25°C (68° to 77°F) protect from freezing
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 OTC - DO NOT USE Do not use if you have ever had an allergic reaction to this product or any of its ingredients. OTC - ASK DOCTOR Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. OTC - WHEN USING When using this product do not take more than directed. Taking more than directed may cause drowsiness. OTC - STOP USE Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. OTC - PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. OTC - KEEP OUT OF REACH OF CHILDREN 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