FDA.reportPublic FDA data

Hyland's Fever Reducer Tablets

Manufacturer
Hyland’s Inc. | Hyland's Inc.
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:51

Label at a glance#

ProductFever Reducer
Active ingredientATROPA BELLADONNA, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT
Label structure10 sections

Indications and uses

■ Temporarily reduces fevers and relieves pain

Dosage and administration

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.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily reduces fevers and relieves pain

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Aconitum Napellus 6X HPUS

fever reducer/pain reliever

Belladonna 6X HPUS

(0.0000003% Alkaloids, calculated)

fever reducer/pain reliever

Bryonia Alba 6X HPUS

fever reducer/pain reliever

Gelsemium Sempervirens 6X HPUS

fever reducer/pain reliever

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily reduces fevers and relieves pain

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - DO NOT USE SECTION

Do not use more than directed.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

SPL UNCLASSIFIED SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Other information

OTHER SAFETY INFORMATION

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-4010-1

SINCE 1903

Hyland's

Fever

Reducer*

TOUGH ON PAIN - GENTLE ON YOU

NO ACETAMINOPHEN

NO IBURPTOFEN

NO KNOWN DRUG

INTERACTIONS

HFVRHFVR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4010-1Fever Reducer100 in 1 BOTTLE, PLASTICTABLET1002
54973-4010-1Fever Reducer1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4010FEVER REDUCER (ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOT) TABLET [HYLAND’S INC.]2Current NDC, Legacy NDC, 2 package rows20221213_a3d3b0fb-9fca-52ba-e053-2995a90aa3e9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-401054973-4010-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fever ReducerACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA AND BRYONIA ALBA ROOTHylands Inc.a3d3b0fb-9fca-52ba-e053-2995a90aa3e92022-12-12WarningsExact identifier
ndc (package): 54973-4010-1
ndc (product): 54973-4010
ndc11 (package): 54973401001
spl id: efa4626c-d312-051c-e053-2995a90a27a6
spl set id: a3d3b0fb-9fca-52ba-e053-2995a90aa3e9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.