Headache Relief

Manufacturer: 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#

ProductHeadache Relief

Active ingredientGELSEMIUM SEMPERVIRENS ROOT, IPECAC, ATROPA BELLADONNA, IRIS VERSICOLOR ROOT

Label structure10 sections

Indications and uses

■ Temporarily relieves headaches

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.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Headache Relief

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

■ Temporarily relieves headaches

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 - ASK DOCTOR SECTION

Consult a physician if:

■ symptoms persist for more than 7 days or worsen.

■ new symptoms occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OVERDOSAGE 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 54973-4008-1

SINCE 1903

Hyland's

Headache

Relief *

TOUGH ON PAIN - GENTLE ON YOU

NO ACETAMINOPHEN

NO IBUPROFEN

NO KNOWN DRUG

INTERACTIONS

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54973-4008-1	Headache Relief	1 in 1 CARTON	TABLET	1		2
54973-4008-1	Headache Relief	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-4008	HEADACHE RELIEF (ATROPA BELLADONNA, GELSEMIUM SEMPERVIRENS ROOT, IPECAC AND IRIS VERSICOLOR ROOT) TABLET [HYLAND'S INC.]	2	Current NDC, Legacy NDC, 2 package rows	20221213_a58f376e-90ed-d5f5-e053-2a95a90a0442.zip

Products#

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

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

Headache Relief
Atropa Belladonna, Gelsemium Sempervirens Root, Ipecac and Iris Versicolor Root
ACACIA
LACTOSE MONOHYDRATE
GELSEMIUM SEMPERVIRENS ROOT
IPECAC
ATROPA BELLADONNA
IRIS VERSICOLOR ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-4008	54973-4008-1

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
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
IPECAC	62I3C8233L	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
IRIS VERSICOLOR ROOT	X43D4L3DQC	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Headache Relief	ATROPA BELLADONNA, GELSEMIUM SEMPERVIRENS ROOT, IPECAC AND IRIS VERSICOLOR ROOT	Hyland's Inc.	a58f376e-90ed-d5f5-e053-2a95a90a0442	2022-12-12	Warnings	Exact identifier ndc (package): 54973-4008-1 ndc (product): 54973-4008 ndc11 (package): 54973400801 spl id: efa50f1b-2f79-510f-e053-2a95a90ad548 spl set id: a58f376e-90ed-d5f5-e053-2a95a90a0442

Reported adverse events (FAERS/openFDA)#

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