Indications
USE(S) 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 OTHER REQUIRED WARNINGS Other information For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing. For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn store between 20º to 25º C (68º to 77º F) FDA approved dissolution test specifications differ from USP
Pregnancy and breastfeeding
PREGNANCY/BREASTFEEDING If pregnant or breast-feeding, 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 · SyrupANDA077421-001 · Over the counter
- LORATADINE 1MG/ML · Syrup
At a glance
- Brand name
- Loratadine
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Marksans Pharma
- Status
- Over the counter
- FDA approval
- 21 Nov 2024
- Application
- ANDA219223-001