Tylenol Sinus Severe

Manufacturer
Savings Distributors LLC
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:56:58

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each caplet)

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

Uses

■ temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: ■ sinus congestion and pressure ■ headache ■ nasal congestion ■ minor aches and pains ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever

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.

Directions And Dosage

Directions

■ do not take more than directed (see overdose warning) adults and children 12 years ■ take 2 caplets every 4 hours and over ■ 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 Label Information

Inactive ingredients

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions or comments?

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

Package Label

Label Images#

TylenolSinusSevere_25
TylenolSinusSevere_25

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN3
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY3
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73097-014-022023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe
73097-014-402023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe
73097-014-502023-01-30C16284748780-1f386c649-d43b-0266-e053-dadaa90a7c1aTylenol Sinus Severe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-014-02Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-40Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-40Tylenol Sinus Severe20 in 1 CARTONTABLET, COATED203
73097-014-50Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED23
73097-014-50Tylenol Sinus Severe25 in 1 CARTONTABLET, COATED253

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

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73097-01473097-014-50, 73097-014-40, 73097-014-02
50580-507

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: ■ sinus congestion and pressure ■ headache ■ nasal congestion ■ minor aches and pains ■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ■ temporarily reduces fever

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ do not take more than directed (see overdose warning) adults and children 12 years ■ take 2 caplets every 4 hours and over ■ 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML