KRISTALOSE
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
- KRISTALOSE
- Generic name
- LACTULOSE
- Manufacturer
- Cumberland Pharmaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 535dd1ea-b567-49f7-9a84-8ea91e78c466
- SPL ID
- 85528d56-e38f-4565-9136-c7639b479634
- Version
- 4
- Effective date
- 2018-09-17
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:46
| 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 | 074712 | derived:openfda.application_number |
| application number | ANDA074712 | openfda.application_number | |
| brand name | KRISTALOSE | openfda.brand_name | |
| generic name | LACTULOSE | openfda.generic_name | |
| manufacturer name | Cumberland Pharmaceuticals Inc. | openfda.manufacturer_name | |
| ndc | package | 66220-729-01 | openfda.package_ndc |
| ndc | package | 66220-719-01 | openfda.package_ndc |
| ndc | package | 66220-729-30 | openfda.package_ndc |
| ndc | package | 66220-719-30 | openfda.package_ndc |
| ndc | product | 66220-719 | openfda.product_ndc |
| ndc | product | 66220-729 | openfda.product_ndc |
| ndc11 | package | 66220071901 | derived:openfda.package_ndc |
| ndc11 | package | 66220071930 | derived:openfda.package_ndc |
| ndc11 | package | 66220072901 | derived:openfda.package_ndc |
| ndc11 | package | 66220072930 | derived:openfda.package_ndc |
| rxcui | 1251194 | openfda.rxcui | |
| rxcui | 1251196 | openfda.rxcui | |
| rxcui | 1251192 | openfda.rxcui | |
| rxcui | 1251190 | openfda.rxcui | |
| spl id | 85528d56-e38f-4565-9136-c7639b479634 | id | |
| spl set id | 535dd1ea-b567-49f7-9a84-8ea91e78c466 | set_id | |
| unii | 9U7D5QH5AE | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS A theoretical hazard may exist for patients being treated with lactulose who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H 2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Precise frequency data are not available. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.