TYLENOL SINUS PLUS HEADACHE

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-07
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-06-01 00:36:22

Label at a glance#

ProductTYLENOL SINUS PLUS HEADACHE DAY

Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages 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

store between 20-25°C (68-77°F) do not use if blister unit is torn or broken

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
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- sinus congestion and pressure
- nasal congestion
- minor aches and pains
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
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.

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

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 or nasal congestion 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

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

store between 20-25°C (68-77°F)
do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, 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 50580-598-02

TYLENOL ^®
FOR ADULTS

SINUS
+ HEADACHE

Acetaminophen,
Phenylephrine HCl
Pain Reliever–Fever Reducer,
Nasal Decongestant

DAY
NON-DROWSY

SINUS HEADACHE
SINUS PRESSURE
NASAL CONGESTION

Actual Size

24 CAPLETS

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1046378	Acetaminophen/Phenylephrine (Oral Pill)	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	14
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	14
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	14

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-598-01	TYLENOL SINUS PLUS HEADACHEDAY	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	14
50580-598-01	TYLENOL SINUS PLUS HEADACHEDAY	2 in 1 CARTON	TABLET, FILM COATED	2	14
50580-598-02	TYLENOL SINUS PLUS HEADACHEDAY	2 in 1 CARTON	TABLET, FILM COATED	2	14
50580-598-02	TYLENOL SINUS PLUS HEADACHEDAY	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-598	TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]	14	Current NDC, Legacy NDC, 4 package rows	20241109_e608d214-cc46-4a24-ac85-1040e36e7403.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-598-02	EA - Each	50580-598	7a916260-3b4f-4ee4-a69d-a2595f6b2cca	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
Phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	1
powdered cellulose	INACTIVE INGREDIENT	SMD1X3XO9M	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

TYLENOL SINUS PLUS HEADACHE DAY
Acetaminophen and Phenylephrine hydrochloride
ANHYDROUS CITRIC ACID
CARNAUBA WAX
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C RED NO. 40
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POTASSIUM SORBATE
POWDERED CELLULOSE
SODIUM BENZOATE
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM STARCH GLYCOLATE TYPE A
SUCRALOSE
TITANIUM DIOXIDE
ACETAMINOPHEN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-598	50580-598-01, 50580-598-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
D&C YELLOW NO. 10 ALUMINUM LAKE	CQ3XH3DET6	IACT
FD&C BLUE NO. 1 ALUMINUM LAKE	J9EQA3S2JM	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

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 4 · 189 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii+route 63 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 54 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii+route 63 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 63 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 54 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 54 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii+route 63 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii+route 63 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 54 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 54 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii+route 36 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 54 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 63 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 36 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii+route 63 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii+route 63 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 63 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 54 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii+route 63 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii+route 63 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii+route 63 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii+route 63 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii+route 36 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 54 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 54 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii+route 36 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 54 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 54 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 54 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	PASTE / ORAL		48 mg	Exact identifier — unii+route 36 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii+route 63 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 3 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii+route 63 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
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier ndc (package): 50580-598-01 ndc (package): 50580-598-02 ndc (product): 50580-598 ndc11 (package): 50580059801 ndc11 (package): 50580059802 spl id: 21acf19d-d051-97ca-e063-6294a90a5e41 spl set id: e608d214-cc46-4a24-ac85-1040e36e7403

Reported adverse events (FAERS/openFDA)#

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

TYLENOL SINUS PLUS HEADACHE

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

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#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#