Otc - Active Ingredient
Loratadine 10mg
Loratadine Tablet
FDA Label NDC 73629-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amz789 Llc for the product Loratadine (NDC 73629-003). 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 otc - active ingredient, otc - purpose, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Antihistamine
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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Adults and children 6 years and over 1 tablet daily: no 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
Safe Handling Warning
Other Information ● store between 20-25°C (68-77°F) ● protect from excessive moisture ● do not use if imprinted seal under safety cap is broken or missing
Inactive Ingredient
Inactive Ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate
Package Label.Principal Display Panel
Display Panel (Display)
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