FDA label 35ac116e-68a8-45af-91a7-2e33167d1b37
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
- SPL set ID
- a147459b-d68f-4c6c-989a-610f86ea1e3e
- SPL ID
- 35ac116e-68a8-45af-91a7-2e33167d1b37
- Version
- 2
- Effective date
- 2017-08-04
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:36:07
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 |
|---|---|---|---|
| spl id | 35ac116e-68a8-45af-91a7-2e33167d1b37 | id | |
| spl set id | a147459b-d68f-4c6c-989a-610f86ea1e3e | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Flaxseed oil may increase stool bulk and frequency. Caution is advised in individuals with irritable bowel syndrome (IBS), bowel obstruction, and/or diverticular disease. Flaxseed oil may cause ileus (intestinal blockage). Flaxseed oil may cause a thyroid problem. Flaxseed oil and evening primrose oil may slow blood clotting. Individuals with blood disorders or those taking blood thinning medications, such as aspirin, should consult their medical practitioner before taking this product. Blood clotting times may need to be evaluated. Safety and effectiveness in children have not been established. Avoid taking at the same time with other medications, medical foods, and/or supplements. Please see product ingredients. Consult your healthcare practitioner or pharmacist for more information.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Allergic sensitization is possible in susceptible individuals. Generally well-tolerated if taken in normal amounts. Flaxseed oil increases stool bulk and defecation frequency. If breathing problems, tightness in the throat and/or chest, chest pain, skin hives, rash, itchy or swollen skin, headache, GI upset, or nausea occur, immediately discontinue use and consult your healthcare practitioner.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.