Label: HEADACHE RELIEF- atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root tablet
- NDC Code(s): 54973-4008-1
- 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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- Official Label (Printer Friendly)
- PURPOSE
-
Drug Facts
Active ingredients
Active ingredients
Purpose
Belladonna 12X HPUS
(0.0000000000003% Alkaloids, calculated)
headache
Gelsemium Sempervirens 6X HPUS
headache
Ipecacuanha 6X HPUS
headache
Iris Versicolor 6X HPUS
headache
"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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HEADACHE RELIEF
atropa belladonna, gelsemium sempervirens root, ipecac and iris versicolor root tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-4008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 6 [hp_X] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white (White to Off 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:54973-4008-1 1 in 1 CARTON 04/03/2020 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/03/2020 Labeler - Hyland's Inc. (008316655)