Tylenol Sinus Severe

Product NDC
50580-507
11-digit product format
505800507
Labeler code
50580
Product ID
50580-507_2172ef51-bd7d-a040-e063-6394a90aeac3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-15
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC7a60184f-91a9-4b85-b243-871deca634502024-11-01WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning 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 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 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 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) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Tylenol Sinus Severe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 495W7451VQ, 04JA59TNSJ
Rxcui1243679

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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53855190-7124-8179-f018-e792f7c27f28Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-507-01Tylenol Sinus Severe12 in 1 BLISTER PACKTABLET, COATED1216
50580-507-01Tylenol Sinus Severe2 in 1 CARTONTABLET, COATED216
50580-507-02Tylenol Sinus Severe2 in 1 CARTONTABLET, COATED216
50580-507-02Tylenol Sinus Severe3 in 1 PACKAGETABLET, COATED316
50580-507-03Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED216
50580-507-04Tylenol Sinus Severe50 in 1 CARTONTABLET, COATED5016
50580-507-04Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-507-01EA - Each50580-507ee10d929-4cd2-4906-8663-c84fe7e61be412016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
GuaifenesinACTIVE INGREDIENT495W7451VQTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
GuaifenesinACTIVE MOIETY495W7451VQTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
PhenylephrineACTIVE MOIETY1WS297W6MVTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
hydroxypropyl cellulose (type e)INACTIVE INGREDIENT66O7AQV0RTTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1
triacetinINACTIVE INGREDIENTXHX3C3X673TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-507TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 7 package rows20241103_7a60184f-91a9-4b85-b243-871deca63450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN7a60184f-91a9-4b85-b243-871deca6345016
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD7a60184f-91a9-4b85-b243-871deca6345016
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY7a60184f-91a9-4b85-b243-871deca6345016
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY7a60184f-91a9-4b85-b243-871deca6345016
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY4bff8a41-ec6f-4bc5-a3df-2ea4695d9e246
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY8eecb3f0-eb5e-e847-e053-2995a90a86bd3
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN37e939c6-064b-3548-e063-6294a90a337d1
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1560b3a0-fe81-4e33-b581-20b43511dba31
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD37e939c6-064b-3548-e063-6294a90a337d1
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1560b3a0-fe81-4e33-b581-20b43511dba31
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY37e939c6-064b-3548-e063-6294a90a337d1
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1560b3a0-fe81-4e33-b581-20b43511dba31
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY435b4a2a-d6bf-ec25-e063-6294a90a3f061
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY37e939c6-064b-3548-e063-6294a90a337d1
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1560b3a0-fe81-4e33-b581-20b43511dba31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-507-01505800507012 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK2 blister pack2015-05-150000-00-00NoNoCurrent
50580-507-02505800507023 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK3 carton2020-07-06NoNoCurrent
50580-507-03505800507032 TABLET, COATED in 1 POUCH (50580-507-03) 2017-07-170000-00-00NoNoCurrent
50580-507-045058005070450 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH50 pouch2017-07-170000-00-00NoNoCurrent