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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.