FERRIC RED: 12 Adverse Event Reports & Safety Profile
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Active Ingredient: FERRIC OXIDE RED · Route: ORAL · Manufacturer: Hahnemann Laboratories, INC. · HUMAN OTC DRUG · FDA Label: Available
First Report: 20141106 · Latest Report: 20201001
What Are the Most Common FERRIC RED Side Effects?
All FERRIC RED Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Hepatitis toxic | 5 | 41.7% | 0 | 5 |
Who Reports FERRIC RED Side Effects? Age & Gender Data
Gender: 40.0% female, 60.0% male. Average age: 52.8 years. Most reports from: ES. View detailed demographics →
Is FERRIC RED Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2018 | 5 | 0 | 5 |
| 2020 | 1 | 0 | 0 |
What Is FERRIC RED Used For?
| Indication | Reports |
|---|---|
| Anaemia | 5 |
Official FDA Label for FERRIC RED
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses temporarily helps relieve: anorectal burning, itching, and discomfort associated with hemorrhoids temporarily: reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders shrinks hemorrhoidal tissue protects inflamed perianal skin and irritated areas
Dosage & Administration
Directions adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. For external hemorrhoids, apply a small amount of ointment directly to the affected area up to 4 times daily. FOR INTRARECTAL USE (internal hemorrhoids): Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Squeeze a small amount (2 g) of the ointment into the rectum. Remove and discard used applicator. Apply to the affected area up to 4 times daily. children under 12 years of age: consult a doctor.
Known Adverse Reactions
ADVERSE REACTION DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PKWY, CHESAPEAKE,VA 23320 USA MADE IN THE US WITH US AND FOREIGN COMPONENTS 100% SATISFACTION OR YOUR MONEY BACK! NOT 100% SATISFIED? Return within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
Warnings
Warnings For External Use Only Do not use in the eyes on deep or puncture wounds on animal bites on serious burns. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, stop use and consult a doctor Stop use and ask a doctor if condition worsens or does not improved within 7 days you experience bleeding Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active Ingredients Purpose Pramozine HCl .... 1% ............
Anesthetic/Analgesic
Zinc Oxide .........0.4% ............
Skin Protectant
Calamine ...........0.4% ............
Skin
Protectant
Inactive Ingredients
Inactive Ingredient Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).