TBX-Free

Manufacturer: Dalian Jixin Electronic Information Co., Ltd.
Effective date: 2015-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:06:58

Label at a glance#

ProductTBX-Free

Active ingredientCYTISINE

Label structure9 sections

Contacts and useful links#

PhoneLabel contact1-800-965-1594

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Cytisine 8mg

OTC - PURPOSE SECTION

Purpose
Treatment of chronic nicotinism

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a poison control center right away.

INDICATIONS & USAGE SECTION

Use
Smoking cessation treatment

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Adults 18 years or over

Begin using TBX-Free on your quit day

It is important to complete treatment. If you feel you need to use TBX-Free to keep from smoking, talk to your health care provider.

WARNINGS SECTION

Warnings
Do not use: in conjunction with another smoking cessation product; if you are taking prescription medication for depression or asthma; if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor or pharmacist before use if you have: heart disease or an irregular heartbeat; high blood pressure; stomach ulcers; diabetes; allergies to other medication
Stop use and speak to a doctor if any of the following occur: mouth, teeth, or jaw problems, irregular heartbeat or palpitations; you develop symptoms of an allergic reaction (such as difficulty breathing or a rash)

INACTIVE INGREDIENT SECTION

Inactive Ingredients
pullulan, natural mint extract, sugar, menthol, licorice, aspartame

OTHER SAFETY INFORMATION

OTHER SAETY INFORMATION

Protect from excessiv moisture and heat

Store between 15º and 25º C (59º to 77 º F)

QUESTIONS OR COMMENTS

1-800-965-1594

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TBX LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69461-001-01	2020-01-31	C162847	48780-1	9d75b9d0-ac0f-f424-e053-dadaa90a57ce	24fdfded-5d47-07a4-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69461-001-01	TBX-Free	110 mg in 1 BOX	STRIP	110		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69461-001	TBX-FREE (CYTISINE) STRIP [DALIAN JIXIN ELECTRONIC INFORMATION CO., LTD.]	2	Legacy NDC, 1 package rows	20151130_24fdfded-5d47-07a4-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CYTISINE	ACTIVE INGREDIENT	53S5U404NU	2
CYTISINE	ACTIVE MOIETY	53S5U404NU	2
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	2
LICORICE	INACTIVE INGREDIENT	61ZBX54883	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
MINT	INACTIVE INGREDIENT	FV98Z8GITP	2
PULLULAN	INACTIVE INGREDIENT	8ZQ0AYU1TT	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2

Products#

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

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

TBX-Free
cytisine
SUCROSE
MENTHOL
LICORICE
PULLULAN
MINT
ASPARTAME

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69461-001	69461-001-01

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
SUCROSE	C151H8M554	IACT
MENTHOL	L7T10EIP3A	IACT
LICORICE	61ZBX54883	IACT
PULLULAN	8ZQ0AYU1TT	IACT
CYTISINE	53S5U404NU	ACTIB
MINT	FV98Z8GITP	IACT
ASPARTAME	Z0H242BBR1	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 92 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / ORAL		87 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SOLUTION / ORAL	233 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GUM, CHEWING / BUCCAL		89 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL		195 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	FILM, EXTENDED RELEASE / BUCCAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FOR SUSPENSION / ORAL		15 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, FILM COATED / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET / SUBLINGUAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates

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
24fdfded-5d48-07a4-e054-00144ff8d46c			24fdfded-5d47-07a4-e054-00144ff8d46c	2015-11-20	Warnings	Exact identifier spl id: 24fdfded-5d48-07a4-e054-00144ff8d46c spl set id: 24fdfded-5d47-07a4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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