FDA label 2145d850-8607-4fb6-9ffb-a22e0adb7411

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
a017eb78-8c70-4b59-b7c0-22ec6945c1a1
SPL ID
2145d850-8607-4fb6-9ffb-a22e0adb7411
Version
2
Effective date
2018-04-30
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:19

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 Adverse Reactions: occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage. Do not use more than directed The treatment of any anemic condition should be under the advice and supervision of a physician Ask a doctor or pharmacist before use if you are taking oral Tetracycline antibiotics. Oral iron products interfere with absorption of oral tetracycline antibiotics. These products should not be taken within two hours of each other. When using this product may occasionally cause constipation or diarrhea may cause temporary staining of the teeth (this is less likely when diluted) If pregnant or breast-feeding ask a health professional before use. Keep this and all drugs out of reach of children. Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away. Treatment of overdose: quickly induce vomiting, then feed eggs and milk until gastric lavage can be done. Lavage with 1 percent Sodium Bicarbonate and administer an iron chelating agent (such as deferoxamine mesylate) BAL should not be used. Gastric lavage should not be performed after the first hour because the danger of perforation due to gastric necrosis. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary. Directions Mix with water or fruit juice to avoid temporary staining of the teeth, do not mix with milk or wine-based vehicles Adults and children 12 years of age and over 1 teaspoonful daily, or as directed by a physician Children under 12 years of age Consult a physician

warnings table

<table width="50%"> <col width="45%" align="center" valign="middle"/> <col width="55%" align="center" valign="middle"/> <tbody> <tr styleCode="Botrule"> <td>Adults and children 12 years of age and over</td> <td>1 teaspoonful daily, or as directed by a physician</td> </tr> <tr styleCode="Botrule"> <td>Children under 12 years of age</td> <td>Consult a physician</td> </tr> </tbody> </table>

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions: occasional gastrointestinal discomfort such as nausea dose related bowel effects (such as constipation or diarrhea), gastrointestinal effects may be minimized by the administration with or immediately after meals and bowel effects reduced by giving the minimum effective dosage.

Reported adverse events (FAERS/openFDA)#

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