Silicea
Silicea is an FDA drug label for the active ingredient SILICON DIOXIDE manufactured by Boiron administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231115.
- Generic name
- SILICON DIOXIDE
- Manufacturer
- Boiron
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 0220-4684
- Application
- N/A
- Label effective
- 20231115
About this product
Silicea is an FDA-registered drug product whose active ingredient is SILICON DIOXIDE. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-4684, label effective 20231115. It is one of 16 FDA drug label records sharing the active ingredient SILICON DIOXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing SILICON DIOXIDE are most often described in connection with: irritability due. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Fatigue and irritability due to overwork*
Dosage & Administration
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
More products with the same ingredient
SILICON DIOXIDEHow products containing SILICON DIOXIDE compare
FDA lists 16 drug label records with SILICON DIOXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Boiron | 13 |
| — | — | Hyland's Inc. | 3 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0803-2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA | Boiron Inc. | Class III | Terminated | 20180523 |
| D-0861-2021 | Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol, Contains: Dulcamara 10x, Nitricum Acidum 12x, Thuja Occidentalis 10x, Antimonium Crudum 12x, Calcarea Cadbonica 12x, Silicea 12x, WHP Homeopathic Medicine, FOr Manufacturing Use Only. 1.957 kg Lactose Manufactured by Wasington Homeopathic Products 260 JR Hawvermale Way, Berkeley Springs WV 25411. Marketed by: Health Specialty | Washington Homeopathic Products, Inc. | Class II | Terminated | 20211006 |
| D-0503-2020 | Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6. | Washington Homeopathic Products, Inc. | Class II | Terminated | 20191127 |
| D-0864-2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4. | Standard Homeopathic Company | Class I | Terminated | 20170531 |
Frequently asked questions
What is Silicea used for?
Fatigue and irritability due to overwork*
Who makes Silicea?
Boiron is the labeler of record for Silicea. 16 FDA label records share the active ingredient SILICON DIOXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Silicea come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Silicea prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing SILICON DIOXIDE?
Yes. 16 FDA drug label records list SILICON DIOXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Silicea been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.