FDA.reportPublic FDA data

Tylenol Sinus Severe, TRAVEL BASIX

Manufacturer
Lil Drug Store Products, Inc
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:22:17

Label at a glance#

ProductTylenol Sinus Severe, CVP HEALTH
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and 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

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

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 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

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

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
  • 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

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 yearsask 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, 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)

SPL UNCLASSIFIED SECTION

Product distributed by: JOHNSON & JOHNSON CONSUMER INC.
McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA

Repackaged and distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®
FOR ADULTS

SINUS SEVERE

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

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY
NON-DROWSY

6
Caplets
3 POUCHES OF 2 CAPLETS EACH

Lil'
DrugStore ®

PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton
PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton

Tylenol Sinus Severe, CVP ® HEALTH, 4ct - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®
FOR ADULTS

SINUS SEVERE

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

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY
NON-DROWSY

[caplets image]

4
Caplets
2 POUCHES OF 2 CAPLETS EACH

[CVP ® HEALTH logo]

PDP/PackagePDP/Package

Tylenol Sinus Severe, TRAVEL BASIX, 4ct - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®
FOR ADULTS

SINUS SEVERE

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

  • SINUS HEADACHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY
NON-DROWSY

[caplets image]

4
Caplets
2 POUCHES OF 2 CAPLETS EACH

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

Tylenol ® Sinus Severe 25ct, Lil' Drug Store® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®

FOR ADULTS

SINUS SEVERE

Acetaminophen, Phenylephrine HCI, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant

  • SINUS HEADCHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY

NON-DROWSY

[caplets (2) image]

25 Pouches of 2 Caplets each

[Lil' Drug Store ® logo]

PDP/PackagePDP/Package

Tylenol ® Sinus Severe 30ct, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TYLENOL ®

FOR ADULTS

SINUS SEVERE

Acetaminophen, Phenylephrine HCI, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant

  • SINUS HEADCHE
  • SINUS PRESSURE
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

DAY

NON-DROWSY

[caplets (2) image]

30 Pouches of 2 Caplets each
[Lil' Drug Store ® logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243679acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN10
1243679acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD10
1243679APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY10
1243679APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY10

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6457-7Tylenol Sinus Severe, Lil Drug Store25 in 1 CARTONTABLET, COATED2510
66715-6457-7Tylenol Sinus Severe, Lil Drug Store2 in 1 POUCHTABLET, COATED210
66715-6457-8Tylenol Sinus Severe, Lil Drug Store2 in 1 POUCHTABLET, COATED210
66715-6457-8Tylenol Sinus Severe, Lil Drug Store30 in 1 CARTONTABLET, COATED3010
66715-6557-2Tylenol Sinus Severe, CVP HEALTH2 in 1 POUCHTABLET, COATED210
66715-6557-2Tylenol Sinus Severe, CVP HEALTH2 in 1 CARTONTABLET, COATED210
66715-7857-2Tylenol Sinus Severe, TRAVEL BASIX2 in 1 POUCHTABLET, COATED210
66715-7857-2Tylenol Sinus Severe, TRAVEL BASIX2 in 1 CARTONTABLET, COATED210
66715-9757-2Lil Drug Store Tylenol Sinus Severe2 in 1 CARTONTABLET, COATED210
66715-9757-2Lil Drug Store Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED210
66715-9757-3Lil Drug Store Tylenol Sinus Severe3 in 1 CARTONTABLET, COATED310
66715-9757-3Lil Drug Store Tylenol Sinus Severe2 in 1 POUCHTABLET, COATED210

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-655766715-6557-2
66715-975766715-9757-2, 66715-9757-3
66715-785766715-7857-2
66715-645766715-6457-7, 66715-6457-8

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYDROXYPROPYL CELLULOSE (70000 WAMW)66O7AQV0RTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CARNAUBA WAXR12CBM0EIZIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Sinus Severe, Lil Drug StoreACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDELil Drug Store Products, Inc88b68447-b016-4d5b-a5e3-c4ebccb14f8c2025-12-10WarningsExact identifier
ndc (package): 66715-9757-3
ndc (package): 66715-6457-8
ndc (package): 66715-6557-2
ndc (package): 66715-9757-2
ndc (package): 66715-6457-7
ndc (package): 66715-7857-2
ndc (product): 66715-7857
ndc (product): 66715-9757
ndc (product): 66715-6457
ndc (product): 66715-6557
ndc11 (package): 66715785702
ndc11 (package): 66715975702
ndc11 (package): 66715645707
ndc11 (package): 66715655702
ndc11 (package): 66715975703
ndc11 (package): 66715645708
spl id: 459f7dbe-5021-08d1-e063-6294a90a8924
spl set id: 88b68447-b016-4d5b-a5e3-c4ebccb14f8c

Reported adverse events (FAERS/openFDA)#

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