FDA label 9850a9df-2dd8-45b5-b2d5-ed55901f9986

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
41f10fa8-2dd2-4fc5-ad29-b4f7a63ab3cb
SPL ID
9850a9df-2dd8-45b5-b2d5-ed55901f9986
Version
3
Effective date
2024-10-17
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:32:46

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Drug I nteraction P recaution: D o not give this product to your child if your child is presently taking mineral oil , unless directed by a doctor. Ask a doctor before using any laxative if your child has a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week If constipation continues after 1 week of use, contact your child's doctor Stop using this product and consult a doctor if your child has rectal bleeding no bowel movement within 72 hours of using this product These symptoms may be signs of a serious condition. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.