Active Ingredient (In Each Tablet)
Loratadine, USP 10 mg
Allergy Relief Tablet
FDA Label NDC 57896-658
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Allergy Relief (NDC 57896-658). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose and throat
- itchy, watery eyes
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 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.
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.
Directions
| adults and children
12 years and over | 1 tablet daily; not more
than 1 tablet in 24 hours |
| children under 12
years of age | ask a doctor |
| consumers with liver
or kidney disease | ask a doctor |
Other Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store between 20° to 25°C (68° to 77°F)
- protect from light
Inactive Ingredients
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions?
call 1-800-540-3765
Package Label
* Please review the disclaimer below.
