warnings
WARNINGS Warnings
Loratadine 10mg
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Loratadine 10mg
- Generic name
- LORATADINE 10MG
- Manufacturer
- MARKSANS PHARMA LIMITED
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 3360d02d-612d-4cc5-acc9-2cc93713c387
- SPL ID
- aa667b5f-a4ac-4129-bae9-f9c1de776629
- Version
- 4
- Effective date
- 2024-11-25
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:19:02
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 219223 | derived:openfda.application_number |
| application number | ANDA219223 | openfda.application_number | |
| brand name | Loratadine 10mg | openfda.brand_name | |
| generic name | LORATADINE 10MG | openfda.generic_name | |
| manufacturer name | MARKSANS PHARMA LIMITED | openfda.manufacturer_name | |
| ndc | package | 25000-092-79 | openfda.package_ndc |
| ndc | package | 25000-092-81 | openfda.package_ndc |
| ndc | package | 25000-092-03 | openfda.package_ndc |
| ndc | package | 25000-092-80 | openfda.package_ndc |
| ndc | product | 25000-092 | openfda.product_ndc |
| ndc11 | package | 25000009281 | derived:openfda.package_ndc |
| ndc11 | package | 25000009280 | derived:openfda.package_ndc |
| ndc11 | package | 25000009203 | derived:openfda.package_ndc |
| ndc11 | package | 25000009279 | derived:openfda.package_ndc |
| rxcui | 311372 | openfda.rxcui | |
| spl id | aa667b5f-a4ac-4129-bae9-f9c1de776629 | id | |
| spl set id | 3360d02d-612d-4cc5-acc9-2cc93713c387 | set_id | |
| unii | 7AJO3BO7QN | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.