Warnings
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of
reach of children. In case of accidental overdose, call a doctor or poison control.
Keylosa
FDA Label NDC 83146-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Novian Pharmaceuticals for the product Keylosa (NDC 83146-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, storage and handling, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Storage And Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Inactive Ingredient
Other Ingredients: Cellulose (capsule), Magnesium Stearate
Package Label.Principal Display Panel
Label (Keylosalabel)
* Please review the disclaimer below.
