Severe Sinus Congestion And Pain

Severe Sinus Congestion And Pain
SPL v4
SPL
SPL Set ID c296efd0-5030-4a26-a9b0-e66423d995dc
Route
ORAL
Published
Effective Date 2024-10-30
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
Crospovidone Starch, Corn Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Povidone Silicon Dioxide Sodium Starch Glycolate Type A Corn Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44527 Shape: capsule Color: white Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-30

Description

Drug Facts

Purpose

Pain reliever/fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this productdo not exceed recommended dose

Section 50568-5

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

Section 50569-3

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)

Section 50570-1

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.

Section 53414-9

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

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

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

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

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

• store between 20-25° C (68-77° F)

Inactive Ingredients

com starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Compare to the active ingredients in Tylenol® Sinus Severe

Severe Sinus Congestion & Pain



Acetaminophen,

Guaifenesin, Phenylephrine HCl

Carton

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this productdo not exceed recommended dose

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

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

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

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

Overdose Warning (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 (Other information)

• store between 20-25° C (68-77° F)

Inactive Ingredients (Inactive ingredients)

com starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients in Tylenol® Sinus Severe

Severe Sinus Congestion & Pain



Acetaminophen,

Guaifenesin, Phenylephrine HCl

Carton

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)