Indications
Uses 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
Warnings and precautions
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.
Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
Pregnancy and breastfeeding
Pregnancy/Breastfeeding ask a health professional before use.
Composition
- Active ingredients
- LORATADINE 10MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- LORATADINE 10MG · TabletANDA076301-001 · Over the counter
- LORATADINE 10MG · TabletANDA210722-001 · Over the counter
- LORATADINE 5MG · Tablet, orally disintegratingANDA212795-001 · Over the counter
- LORATADINE 1MG/ML · SuspensionNDA021734-001 · Discontinued
- LORATADINE 1MG/ML · SyrupANDA075505-001 · Discontinued
- LORATADINE 10MG · TabletANDA076134-001 · Over the counter
- LORATADINE 1MG/ML · Syrup
At a glance
- Brand name
- Loratadine
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Hetero Labs LTD V
- Status
- Over the counter
- FDA approval
- 28 Jul 2023
- Application
- ANDA211718-001