Active Ingredient(S)
Loratadine 10mg
Allergy Relief Tablet
FDA Label NDC 53117-414
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by First Aid Direct for the product Allergy Relief (NDC 53117-414). 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(s), purpose, use(s), do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Use(S)
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
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
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
if an allergic reaction to this product occurs. Seek medical help right away.
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
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
Other Information
- do not use if blister unit is torn or
Storage
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate
Questions
1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)
Principal Display Panel
Allergy Relief Loratadine (414 Allergy Relief 1)
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