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| Product NDC Code | 41226-686 | ||||
|---|---|---|---|---|---|
| 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 | ANDA206214 | ||||
| Labeler Name | KROGER COMPANY | ||||
| 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.LORATADINE 10MG
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.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.FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.
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.TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR 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.ANTIHISTAMINE
Spl product data elements
Usually a list of ingredients in a drug product.LORATADINE LORATADINE FD&C BLUE NO. 1 GELATIN POLYSORBATE 80 POVIDONE WATER SORBITOL CAPRYLIC/CAPRIC MONO/DIGLYCERIDES LORATADINE LORATADINE 21
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.image description
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.IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Storage and handling
Information about safe storage and handling of the drug product.STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT) 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.DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS. WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED. TAKING MORE THAN DIRECTED 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.
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