FDA label 5358f5e8-7ac5-4567-956e-bfb976421be6

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
f1b28346-9338-4dfe-9752-002da637e239
SPL ID
5358f5e8-7ac5-4567-956e-bfb976421be6
Version
4
Effective date
2025-04-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:58:20

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 Do not use if • you have abdominal pain, nausea or vomiting • you have difficulty in swallowing • you have noticed a sudden change in bowel habits that persists over a period of 2 weeks Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Stop use and ask a doctor if • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing • you fail to have a bowel movement after use • rectal bleeding occurs • symptoms persist more than 1 week Drug interaction precaution: Contains calcium. If you are taking any form of tetracycline antibiotic, this product should be taken 1 hour before or 2 hours after you have taken the antibiotic Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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