FDA.reportPublic FDA data

Headache

Manufacturer
Hyland's | Standard Homeopathic Company
Effective date
2017-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:12:30

Label at a glance#

ProductHeadache
Active ingredientATROPA BELLADONNA, GELSEMIUM SEMPERVIRENS ROOT, IRIS VERSICOLOR ROOT, IPECAC
Label structure7 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Belladonna 12X HPUSheadache

(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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

symptoms persist for more than 7 day or worsen.

If pregnant or breast-feeding,

SPL UNCLASSIFIED SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

In case of emergency,

SPL UNCLASSIFIED SECTION

contact a medical professional or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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)

SPL UNCLASSIFIED SECTION

OTHER SAFETY INFORMATION

  • 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

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose N.F.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

OTC - PURPOSE SECTION

Natural Relief for Headache Due to Stress or Illnes

Principal Display Panel-100 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3228-1

Hyland's®

HOMEOPATHIC

Headache

Natural Relief for

Headache Due to

Stress or Illness*

100

TABLETS

11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-322854973-3228-1

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
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
IPECAC62I3C8233LACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d43da267-2a1c-00b4-e053-2995a90a229a57eb180e-88d1-27ea-e053-2a91aa0ad4052021-12-28WarningsExact identifier
spl set id: 57eb180e-88d1-27ea-e053-2a91aa0ad405

Reported adverse events (FAERS/openFDA)#

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