Version
v9
Loratadine — v9
Loratadine
6 Views
Effective date
September 22, 2025
Original packager
Yes
Sections captured
17
Identifiers
- Document ID
- c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0
- Set ID
- 679164cc-7505-7ed4-13fe-87f06cb777d8
- Application numbers
- ANDA076471
- Product NDCs
- 60505-0147
- Package NDCs
- 60505-0147-1, 60505-0147-8
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- Loratadine
- Generic names
- LORATADINE
- Manufacturer names
- Apotex Corp.
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- LORATADINE
- Routes
- ORAL
- Pharmacologic class (PE)
- —
- Pharmacologic class (EPC)
- —
- Pharmacologic class (CS)
- —
- Mechanism of action
- —
Other identifiers
- NUI
- —
- RxCUI
- 311372
- UNII
- 7AJO3BO7QN
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredient (in each tablet) Loratadine 10 mg
Ask Doctor (1)
Sequence 1
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Do Not Use (1)
Sequence 1
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Dosage And Administration (1)
Sequence 1
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
Dosage And Administration Table (1)
Sequence 1
| 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 |
Inactive Ingredient (1)
Sequence 1
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Indications And Usage (1)
Sequence 1
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)
Sequence 1
PRINCIPAL DISPLAY PANEL - 10 mg APOTEX CORP. NDC 60505-0147-1 Loratadine Tablets 10 mg Non-Drowsy* Antihistamine/ Original Prescription Strength † Compare to the active ingredient in Claritin ® Tablets Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose
Purpose (1)
Sequence 1
Purpose Antihistamine
Spl Product Data Elements (1)
Sequence 1
Loratadine Loratadine LORATADINE LORATADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE LOR;10;APO 10mg-100btl
Spl Unclassified Section (2)
Sequence 1
Drug Facts
Sequence 2
Questions or comments? Call 1-800-706-5575 , weekdays, 8:30 am - 5:00 pm Eastern Standard Time Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: August 2018
Spl Unclassified Section Table (1)
Sequence 1
| Manufactured by: | Manufactured for: |
| Apotex Inc. | Apotex Corp. |
| Toronto, Ontario | Weston, Florida |
| Canada M9L 1T9 | 33326 |
Stop Use (1)
Sequence 1
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Storage And Handling (1)
Sequence 1
Other information safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing store between 2°C and 30°C (36°F and 86°F) protect from excessive moisture
Warnings (2)
Sequence 1
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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Sequence 2
If pregnant or breast-feeding, ask a health professional before use.
When Using (1)
Sequence 1
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
OpenFDA raw payload
{'application_number': ['ANDA076471'],
'brand_name': ['Loratadine'],
'generic_name': ['LORATADINE'],
'is_original_packager': [True],
'manufacturer_name': ['Apotex Corp.'],
'package_ndc': ['60505-0147-1', '60505-0147-8'],
'product_ndc': ['60505-0147'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['ORAL'],
'rxcui': ['311372'],
'spl_id': ['c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0'],
'spl_set_id': ['679164cc-7505-7ed4-13fe-87f06cb777d8'],
'substance_name': ['LORATADINE'],
'unii': ['7AJO3BO7QN']}