Active Ingredient
Loratadine 10mg
Allergy Tablet
FDA Label NDC 63654-309
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Selder, S.a. De C.v. for the product Allergy (NDC 63654-309). 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, purpose, uses, do not use, ask a doctor before use, when using this product, stop use and ask a doctor, pregnancy/breastfeeding, 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 or other upper respiratory allergies:
■ sneezing
■ runny nose
■ itchy, watery eyes
■ 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
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.
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
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
■ store between 20° to 25°C (68° to 77° F)
■ protect from excessive moisture
■ do not use if blister packaging is torn or open
Inactive Ingredients
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions Or Comments?
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