FEVER REDUCER- aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tablet

Fever Reducer by

Drug Labeling and Warnings

Fever Reducer by is a Homeopathic medication manufactured, distributed, or labeled by Hyland’s Inc., Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Temporarily reduces fevers and relieves pain

Drug Facts

Active ingredients

• 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

■ Temporarily reduces fevers and relieves pain

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.

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.

Other information

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

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

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

INGREDIENTS AND APPEARANCE

FEVER REDUCER 
aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4010-1	1 in 1 CARTON	03/30/2020
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/30/2020

Labeler - Hyland’s (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-4010) , pack(54973-4010) , label(54973-4010)