warnings
WARNINGS Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor
GAVILAX
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
- GAVILAX
- Generic name
- POLYETHYLENE GLYCOL 3350
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 19672e23-1606-497e-a112-939af33af195
- SPL ID
- ced29c35-5d51-4eb1-8119-1c988d29a592
- Version
- 8
- Effective date
- 2025-12-08
- Source export date
- 2026-10-22
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-22/6983e0043e02b7c5b54ab7cac56ed79eae60cfdeef16cfdd964bf5591555d29c/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
- Import run
- 20261023T001338Z
- Imported at
- 2026-10-23 00:23:29
| 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 | 091077 | derived:openfda.application_number |
| application number | ANDA091077 | openfda.application_number | |
| brand name | GAVILAX | openfda.brand_name | |
| generic name | POLYETHYLENE GLYCOL 3350 | openfda.generic_name | |
| manufacturer name | Lupin Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 43386-312-85 | openfda.package_ndc |
| ndc | package | 43386-312-08 | openfda.package_ndc |
| ndc | package | 43386-312-07 | openfda.package_ndc |
| ndc | package | 43386-312-14 | openfda.package_ndc |
| ndc | product | 43386-312 | openfda.product_ndc |
| ndc11 | package | 43386031208 | derived:openfda.package_ndc |
| ndc11 | package | 43386031285 | derived:openfda.package_ndc |
| ndc11 | package | 43386031207 | derived:openfda.package_ndc |
| ndc11 | package | 43386031214 | derived:openfda.package_ndc |
| rxcui | 876214 | openfda.rxcui | |
| rxcui | 876193 | openfda.rxcui | |
| spl id | ced29c35-5d51-4eb1-8119-1c988d29a592 | id | |
| spl set id | 19672e23-1606-497e-a112-939af33af195 | set_id | |
| unii | G2M7P15E5P | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.