FDA label 3e8eedf0-4fb7-4268-a8b9-00d3afb83df7

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
f116b0bb-3bda-421a-ba40-827c56c1ca9c
SPL ID
3e8eedf0-4fb7-4268-a8b9-00d3afb83df7
Version
3
Effective date
2025-05-09
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 02:58:19

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 Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers Do not use ▪ if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. ▪ with other acid reducers ▪ if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have ▪ frequent chest pain ▪ frequent wheezing, particularly with heartburn ▪ unexplained weight loss ▪ nausea or vomiting ▪ stomach pain ▪ had heartburn over 3 months. This may be a sign of a more serious condition. ▪ heartburn with lightheadedness, sweating or dizziness ▪ chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness Stop use and ask a doctor if ▪ your heartburn continues or worsens ▪ you need to take this product for more than 14 days If pregnant or breast-feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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