Sudafed Sinus Congestion Plus Cold Severe Day And Night Kit
FDA Label NDC 50580-660

SUDAFED® SINUS CONGESTION + COLD SEVERE DAY

Drug Facts

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.

EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT

Drug Facts

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.

Active ingredients

Active ingredients

■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ helps clear nasal passages
■ promotes nasal and sinus drainage
■ temporarily reduces fever

■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ sneezing and runny nose
■ helps clear nasal passages ■ temporarily reduces fever

​Warnings

This product contains acetaminophen. 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

This product contains acetaminophen. 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

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

■ 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

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ with any other product containing diphenhydramine, even one used on skin

■ 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

■ liver disease
■ heart disease

■ high blood pressure

■ thyroid disease
■ diabetes

■ trouble urinating due to an enlarged prostate gland

■ liver disease

■ heart disease
■ high blood pressure

■ thyroid disease

■ diabetes
■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

■ glaucoma

taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

When using this product

■ do not exceed recommended dose

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ alcohol, sedatives and tranquilizers may increase drowsiness
■ avoid alcoholic drinks

■ be careful when driving a motor vehicle or operating machinery

■ nervousness, dizziness, or sleeplessness occur

■ pain or nasal congestion 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
These could be signs of a serious condition.

■ nervousness, dizziness, or sleeplessness occur
■ pain or nasal congestion 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
These could be signs of a serious condition.

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

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

Keep out of reach of children.

Keep out of reach of children.

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.

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.

• do not take more than directed (see overdose warning)

adults and children 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

• do not take more than directed (see overdose warning)

adults and children 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

■ store between 20 - 25°C (68 - 77°F)
■ do not use if blister unit is torn or broken​

■ store between 20 - 25°C (68 - 77°F)
■ do not use if blister unit is torn or broken​

candelilla wax, croscarmellose sodium, crospovidone, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, pregelatinized starch, titanium dioxide, zinc stearate

candelilla wax, croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, titanium dioxide, zinc stearate

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Warnings

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

■ taking sedatives or tranquilizers

NEW

NDC 50580-660-16

SUDAFED

SINUS

CONGESTION + COLD SEVERE

Acetaminophen,
Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Nasal Decongestant

DAYTIME

• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES

actual size

Acetaminophen,
Diphenhydramine HCI, Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Antihistamine,
Nasal Decongestant

NIGHTTIME

• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES
• RUNNY NOSE
• SNEEZING

actual size

12 TABLETS; 4 TABLETS; 16 TABLETS TOTAL

Sudafed-1 (Sudafed 1)