FDA label e047250b-07da-4164-b23d-365727189806

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
fadb8d58-210e-44f8-9ec1-d94290091596
SPL ID
e047250b-07da-4164-b23d-365727189806
Version
3
Effective date
2011-01-19
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:02:26

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

Warnings Allergy alert: Do not use if you are allergic to cimetidine 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 Ask a doctor or pharmacist before use if you are taking theophylline (oral asthma medicine) warfarin (blood thinning medicine) phenytoin (seizure medicine) If you are not sure you are taking one of these medicines, talk to your doctor or pharmacist. Drug Interaction Warnings: Tagamet HB 200 ® may interfere with the action of drugs prescribed by your doctor. Check with your doctor before taking Tagamet HB 200 ® if you are taking blood thinning medication (e.g. Warfarin) or drugs prescribed for asthma (e.g. Theophylline) or epilepsy (e.g. Phenytoin). Brand names of some medicines which contain one of these ingredients include: THEOPHYLLINE THEO-DUR ® Theochron ® Slo-Bid ® Uniphyl ® Theo-24 ® WARFARIN Coumadin ® PHENYTOIN Dilantin ® There may be other medicines that contain one of these ingredients. If in doubt about this or about possible effects of Tagamet HB 200 on any other medicines you are taking, talk to your doctor or pharmacist. Read the directions and warnings before taking this medication. Stop use and ask a doctor if your heartburn continues or worsens stomach pain continues 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.

warnings table

<table width="432.000" ID="id_3b04acf1-c132-417e-9083-d9f1cd9f8b39"> <caption ID="id_aae002ee-94e2-4403-9d6f-9a2691d4e399">Brand names of some medicines which contain one of these ingredients include:</caption> <col width="25.0%"/> <col width="75.0%"/> <tbody> <tr ID="id_aa13e0a2-dcf4-4ce4-868f-ecd98569688b"> <td align="left" valign="top" styleCode="Botrule Toprule Rrule"> <content styleCode="bold">THEOPHYLLINE</content> </td> <td align="left" valign="top" styleCode="Botrule">THEO-DUR<sup>&#xAE;</sup> Theochron<sup>&#xAE;</sup> Slo-Bid<sup>&#xAE;</sup> Uniphyl<sup>&#xAE;</sup> Theo-24<sup>&#xAE;</sup> </td> </tr> <tr ID="id_cc1b334d-bd72-4731-8af2-34bd36142623"> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">WARFARIN</content> </td> <td align="left" valign="top" styleCode="Botrule">Coumadin<sup>&#xAE;</sup> </td> </tr> <tr ID="id_8439d307-e58d-47ef-ac27-544af3406693"> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">PHENYTOIN</content> </td> <td align="left" valign="top" styleCode="Botrule">Dilantin<sup>&#xAE;</sup> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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