TYLENOL

Manufacturer: Kenvue Brands LLC
Effective date: 2026-09-24
Label type: HUMAN OTC DRUG LABEL
Version: 21
Source: daily-update
Hydrated at: 2026-09-30 01:01:37

Label at a glance#

ProductTYLENOL Cold Plus Flu Severe

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Storage and handling

each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if pouch is torn or damaged

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-895-3665

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

*Active ingredients (in each caplet)*	*Purpose*
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

SPL UNCLASSIFIED SECTION

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

each caplet contains: sodium 3 mg
store between 20-25°C (68-77°F)
do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-402-02

TYLENOL ^®

FOR ADULTS

COLD + FLU

SEVERE

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin

Pain Reliever–Fever Reducer, Cough Suppressant,

Nasal Decongestant, Expectorant

HEAD + BODY ACHES
FEVER + SORE THROAT
COUGH
NASAL CONGESTION
MUCUS + CHEST CONGESTION

Actual Size

50 Pouches of 2 Caplets each

Tylenol-1

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1110988	Acetaminophen/Dextromethorphan/guaiFENesin/Phenylephrine (Oral Pill)	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD Active

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0300450270504	GTIN-13: 0300450270504 EAN-13: 0300450270504 GTIN-12: 300450270504 UPC-A: 300450270504 GTIN storage (14 digits): 00300450270504	Tylenol-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-402-01	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-01	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-02	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-02	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-26	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-26	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-72	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-72	2024-02-06	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-01	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-01	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-02	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-02	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-26	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-26	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-72	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe
50580-402-72	2024-01-30	C162847	48780-1	1030e365-43f9-111a-e063-dadaa90a10e2	TYLENOL ® Cold + Flu Severe

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-402-25	EA - Each	50580-402	0cc3391e-bdb0-4261-8768-843eeb5a7dbd	1	2012-07-24
50580-402-26	EA - Each	50580-402	30dba1ec-de87-4165-ada8-eec0bd9a7ef1	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	6
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	6
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	6
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	6
acetaminophen	ACTIVE MOIETY	362O9ITL9D	6
dextromethorphan	ACTIVE MOIETY	7355X3ROTS	6
guaifenesin	ACTIVE MOIETY	495W7451VQ	6
phenylephrine	ACTIVE MOIETY	1WS297W6MV	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	6
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	6
D&C yellow NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	6
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	6
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	6
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	6

Products#

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

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

TYLENOL Cold Plus Flu Severe
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
CARNAUBA WAX
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10 ALUMINUM LAKE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SUCRALOSE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-402	50580-402-26, 50580-402-72, 50580-402-01, 50580-402-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C YELLOW NO. 10 ALUMINUM LAKE	CQ3XH3DET6	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
20	2024-11-01	full-release	2026-06-01 00:33:31

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 3 · 135 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii+route 90 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)	HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	TABLET, FILM COATED / ORAL		15 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 90 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 90 equally ranked IID candidates
D&C yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 90 equally ranked IID candidates
D&C yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 90 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)	HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	TABLET, FILM COATED / ORAL		15 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 90 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 90 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 90 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 90 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 90 equally ranked IID candidates
D&C yellow NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 90 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 90 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 90 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 90 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE (TYPE E)	HYDROXYPROPYL CELLULOSE (70000 WAMW)	66O7AQV0RT	TABLET, FILM COATED / ORAL		15 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 90 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii+route+dosage form 5 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
21aa0501-3ceb-19c5-e063-6294a90a12c6			efb3bfc5-72e9-4221-8d03-e48f3d8e3821	2024-11-01	Warnings	Exact identifier spl set id: efb3bfc5-72e9-4221-8d03-e48f3d8e3821

Reported adverse events (FAERS/openFDA)#

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

TYLENOL

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

Sore throat warning

Do not use

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - WHEN USING SECTION

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

Product Linked Resources#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Older Hydrated Versions#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#