FDA label ff3d82aa-72e0-4003-b1b1-efc34ea390ac

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
c2c82f2e-763a-4459-b18f-e2ca8f22f7f7
SPL ID
ff3d82aa-72e0-4003-b1b1-efc34ea390ac
Version
2
Effective date
2025-05-09
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:09:29

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 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.