Label: FEVER REDUCER- aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tablet
- NDC Code(s): 54973-4010-1
- Packager: Hyland’s Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 12, 2022
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- PURPOSE
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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
- Warnings
- Directions
- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
FEVER REDUCER
aconitum napellus, gelsemium sempervirens root, atropa belladonna and bryonia alba root tabletProduct 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 Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-4010) , pack(54973-4010) , label(54973-4010)