Tylenol ® - DailyMed Details

Tylenol ®

SPL v10

SPL

SPL Set ID 88b68447-b016-4d5b-a5e3-c4ebccb14f8c

Route

ORAL

Published

Effective Date 2022-04-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Carnauba Wax Croscarmellose Sodium Hydroxypropyl Cellulose (70000 Wamw) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Starch, Corn Sucralose Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: TYLENOL;1072 Shape: oval Color: white Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-19 Until 2028-10-31

Description

Drug Facts

Medication Information

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose

Section 50568-5

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

Section 53414-9

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

Section 55105-1

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

Directions

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

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.

Tylenol ®

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]

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

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.

Other Information

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

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)

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.

Tylenol Sinus Severe, Cvp ®

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]

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)

Principal Display Panel 6 Caplet Pouch Carton

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 ^®

Tylenol Sinus Severe, Travel Basix, 4ct Pdp/package

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]

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Directions

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

Do Not Use (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.

Tylenol ®

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]

Liver Warning (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

Overdose Warning (Overdose warning)

Other Information (Other information)

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 ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Stop Use and Ask A Doctor If (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.

Tylenol Sinus Severe, Cvp ® (Tylenol Sinus Severe, CVP ®)

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]

Ask A Doctor Before Use If You Have (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)

Principal Display Panel 6 Caplet Pouch Carton (PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton)

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 ^®

Tylenol Sinus Severe, Travel Basix, 4ct Pdp/package (Tylenol Sinus Severe, TRAVEL BASIX, 4ct - PDP/Package)

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]

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant", "Directions": "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", "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.", "Tylenol ®": "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]", "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", "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.", "Other information": "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": "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)", "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.", "Tylenol Sinus Severe, CVP ®": "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]", "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)", "PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton": "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 ®", "Tylenol Sinus Severe, TRAVEL BASIX, 4ct - PDP/Package": "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]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:36.868621 · Updated: 2026-03-14T23:11:16.641314