Fever Reducer
Fever Reducer is an FDA drug label for the active ingredient ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT manufactured by Hylands Inc. 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 20221212.
- Generic name
- ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT
- Manufacturer
- Hylands Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 54973-4010
- Application
- N/A
- Label effective
- 20221212
About this product
Fever Reducer is an FDA-registered drug product whose active ingredient is ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT. It is labelled by Hylands Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 54973-4010, label effective 20221212. 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 ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT are most often described in connection with: temporarily reduces, relieves pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses ■ Temporarily reduces fevers and relieves pain
Dosage & Administration
Directions Adults and children 12 years and over Dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved. Children under 12 years Consult a physician.
Warnings
Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use more than directed. Stop use and consult a physician if: ■ pain gets worse or lasts more than 7 days. ■ fever gets worse, is consistently 103°F (39.4°C) or higher or lasts more than 3 days. ■ new symptoms occur. ■ redness or swelling is present. Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Recall and safety notices
5 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-0627-2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India | Granules Consumer Health Inc. | Class III | Terminated | 20240814 |
| D-0563-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets. | Family Dollar Stores, Llc. | Class II | Ongoing | 20230510 |
| D-0566-2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles. | Family Dollar Stores, Llc. | Class II | Ongoing | 20230510 |
| D-0564-2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets | Family Dollar Stores, Llc. | Class II | Ongoing | 20230510 |
| D-0183-2023 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5 | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon | Class I | Terminated | 20230201 |
Frequently asked questions
What is Fever Reducer used for?
Uses ■ Temporarily reduces fevers and relieves pain
Who makes Fever Reducer?
Hylands Inc. is the labeler of record for Fever Reducer.
What form does Fever Reducer 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 Fever Reducer 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.
Has Fever Reducer been recalled?
5 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.