Stibium 0.4 Adult Size Special Order
FDA Label NDC 48951-8292

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Stibium 0.4 Adult Size Special Order (NDC 48951-8292). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

Directions: FOR RECTAL USE ONLY.

Dosage & Administration

Insert 1 suppository as needed.

Otc - Active Ingredient

Active Ingredient: 100 gm contains 4 gm Stibium met. 1X

Inactive Ingredient

Inactive Ingredients: Cocoa butter, Hydrogenated vegetable oil, Micronized silica gel

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

KEEP REFRIGERATED OR STORE IN COOL, DRY PLACE. REFRIGERATE TO RESOLIDIFY. Warnings: Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seals on box are broken or missing.

Otc - Questions

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

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