FDA.reportPublic FDA data

Quitters Relief Irritability

Manufacturer
Hyland's Inc.
Effective date
2022-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:55

Label at a glance#

ProductQuitters Relief Irritability
Active ingredientSILVER NITRATE, SULFUR, ACONITUM NAPELLUS WHOLE, ARSENIC TRIOXIDE, ANAMIRTA COCCULUS SEED, DIBASIC POTASSIUM PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, STRYCHNOS IGNATII SEED, DELPHINIUM STAPHISAGRIA SEED, PHOSPHORUS
Label structure10 sections

Indications and uses

■ Temporarily relieves symptoms of irritability associated with smoking cessation, including: ■ anxiousness ■ restlessness ■ nervous tension ■ occasional sleeplessness

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.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves symptoms of irritability associated with smoking cessation, including: anxiousness, restlessness, nervous, tension, occasional sleeplessness

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Aconitum Napellus 30X HPUS

nervous tension

Argentum Nitricum 30X HPUS

nervous tension

Arsenicum Album 30X HPUS

nervousness, restlessness, anxiousness

Cocculus Indicus 30X HPUS

anxiousness, restlessness

Gelsemium Sempervirens 30X HPUS

irritability

Ignatia Amara 30X HPUS

(less than 0.0000000000017% Alkaloids, calculated)

anxiousness, occasional sleeplessness

Kali Phosphoricum 12X HPUS

irritability

Phosphorus 30X HPUS

occasional sleeplessness

Staphysagria 12X HPUS

anxiousness and irritability associated with smoking cessation

Sulphur 30X HPUS

irritability

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 symptoms of irritability associated with smoking cessation, including:

■ anxiousness ■ restlessness ■ nervous tension ■ occasional sleeplessness

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 54973-4007-1

SINCE 1903

Hyland's

QUITTER’S RELIEF

Irritability*

GENTLE RELIEF FOR SMOKING CESSATION SYMPTOMS

Irritability, Anxiousness, Restlessness,

Nervous Tension, Occasional Sleeplessness

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4007QUITTERS RELIEF IRRITABILITY (ACONITUM NAPELLUS WHOLE, ANAMIRTA COCCULUS SEED, ARSENIC TRIOXIDE, DELPHINIUM STAPHISAGRIA SEED, DIBASIC POTASSIUM PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, SILVER NITRATE AND SULFUR) TABLET [HYLAND'S INC.]2Legacy NDC20221217_b115f9e9-933f-e55a-e053-2995a90a0476.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-400754973-4007-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
SILVER NITRATE95IT3W8JZEACTIB
SULFUR70FD1KFU70ACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
PHOSPHORUS27YLU75U4WACTIB

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
413b7cc6-2ca2-0d91-e063-6394a90aa278b115f9e9-933f-e55a-e053-2995a90a04762025-10-15WarningsExact identifier
spl set id: b115f9e9-933f-e55a-e053-2995a90a0476

Reported adverse events (FAERS/openFDA)#

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