FDA.reportPublic FDA data

FDA label e95f0619-c7e9-4c76-e053-2995a90a2e72

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
97978a75-bf85-ba66-e053-2995a90a3b2d
SPL ID
e95f0619-c7e9-4c76-e053-2995a90a2e72
Version
4
Effective date
2022-09-23
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:44

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

MgOH, AlOH, Simethicone 1200/1200/120 mg/30 mL Warnings Ask a doctor before use if you have - kidney disease - a magnesium-restricted diet ___________________________________________________________________ Ask a doctor or pharmacist before use if you are taking a presecription drug. Antacids may interact with certain prescription drugs. ___________________________________________________________________ Stop use and ask a doctor if - you have symptoms that last more than 2 weeks ___________________________________________________________________ If pregnant or breast-feeding, ask a health professional before use.

warnings

Magnesium hydroxide, Aluminum hydroxide, Simethicone 2400/2400/240 mg/30 mL Warnings Ask a doctor before use if you have - kidney disease - a magnesium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. ___________________________________________________________________ Stop use and ask a doctor if - you have symptoms that last for more than 2 weeks. ___________________________________________________________________ If pregnant or breast-feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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