Quitters Relief Headache

Manufacturer: Hyland's Inc.
Effective date: 2022-12-13
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:18:54

Label at a glance#

ProductQuitters Relief Headache

Active ingredientIRIS VERSICOLOR ROOT, DELPHINIUM STAPHISAGRIA SEED, STRYCHNOS NUX-VOMICA SEED, ACONITUM NAPELLUS, ATROPA BELLADONNA

Label structure10 sections

Indications and uses

■ Temporarily relieves headaches associated with smoking cessation

Dosage and administration

Adults ages 18 years and over Dissolve 2 tablets under tongue every 15 minutes up to 4 doses, then every 4 hours until relieved.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves headaches associated with smoking cessation

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose
Aconitum Napellus 6X HPUS	headache
Belladonna 6X HPUS (0.0000003% Alkaloids, calculated)	headache
Iris Versicolor 6X HPUS	headache
Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)	headache
Staphysagria 12X HPUS	headache

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves headaches associated with smoking cessation

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.

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 ages 18

years and over

Dissolve 2 tablets under tongue every 15 minutes up to 4 doses,

then every 4 hours until relieved.

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.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-4005-1

SINCE 1903

Hyland's

QUITTER’S RELIEF

Headache*

GENTLE RELIEF FOR SMOKING CESSATION SYMPTOMS

No Acetaminophen, Ibuprofen

or Caffeine

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-4005	QUITTERS RELIEF HEADACHE (ACONITUM NAPELLUS,ATROPA BELLADONNA,DELPHINIUM STAPHISAGRIA SEED,IRIS VERSICOLOR ROOT AND STRYCHNOS NUX-VOMICA SEED) TABLET [HYLAND'S INC.]	3	Legacy NDC	20221217_b1037662-c879-bb25-e053-2995a90af9af.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Quitters Relief Headache
ACONITUM NAPELLUS,ATROPA BELLADONNA,DELPHINIUM STAPHISAGRIA SEED,IRIS VERSICOLOR ROOT and STRYCHNOS NUX-VOMICA SEED
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
ACACIA
IRIS VERSICOLOR ROOT
DELPHINIUM STAPHISAGRIA SEED
STRYCHNOS NUX-VOMICA SEED
ACONITUM NAPELLUS
ATROPA BELLADONNA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-4005	54973-4005-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
ACACIA	5C5403N26O	IACT
IRIS VERSICOLOR ROOT	X43D4L3DQC	ACTIB
DELPHINIUM STAPHISAGRIA SEED	00543AP1JV	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	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
413b6725-9312-df49-e063-6394a90adaf9			b1037662-c879-bb25-e053-2995a90af9af	2025-10-15	Warnings	Exact identifier spl set id: b1037662-c879-bb25-e053-2995a90af9af

Reported adverse events (FAERS/openFDA)#

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