HEADACHE- atropa belladonna, gelsemium sempervirent root, ipecac and iris versicolor root tablet, soluble
Hyland's

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.

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Hyland's Headache

Drug Facts

Active ingredients	Purpose
Belladonna 12X HPUS	headache
(0.0000000000003% alkaloids, calculated)
Gelsemium Sempervirens 6X HPUS	headache
Ipecac 6X HPUS	headache
Iris Versicolor 6X HPUS	headache
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopreia of the United States.

Uses

Temporarily relieves the symptoms of headache due to stress, illness and mental fatigue.

Stop use and ask a doctor if

symptoms persist for more than 7 day or worsen.

If pregnant or breast-feeding,

ask a health professional before use.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

In case of emergency,

contact a medical professional or Poison Control Center immediately.

Directions

Adults and children 12 years and over: dissolve 2-3 tablets under tongue every 4 hours or as needed.

Children 6 years to under 12 years: 1/2 adult dose

Drug Facts (continued)

do not use if imprinted tamper band is broken or missing
Hyland's may be contacted for emergency information about products 24 hours a day, 7 days per week at (800) 624-9659

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

Natural Relief for Headache Due to Stress or Illnes

Principal Display Panel-100 Tablet Carton

NDC 54973-3228-1

Hyland's®

HOMEOPATHIC

Headache

Natural Relief for

Headache Due to

Stress or Illness*

100

TABLETS

HEADACHE
atropa belladonna, gelsemium sempervirent root, ipecac and iris versicolor root tablet, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3228
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X] in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 g
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X] in 1 g
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	6 [hp_X] in 1 g

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

Product Characteristics
Color	white (White to Off white)	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3228-1	1 in 1 CARTON	03/06/2015
1		100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/06/2015	12/28/2021

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3228) , pack(54973-3228) , label(54973-3228)

Revised: 12/2021

Document Id: d43da267-2a1c-00b4-e053-2995a90a229a

Set id: 57eb180e-88d1-27ea-e053-2a91aa0ad405

Version: 2

Effective Time: 20211228

Hyland's