1149B-TCR-2021-1112

SPL UNCLASSIFIED SECTION

SINUS + HEADACHE DAY

Drug Facts

OTC - PURPOSE SECTION

Uses

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:    ■ headache    ■ sinus congestion and pressure    ■ nasal congestion    ■ minor aches and pains ■ helps decongest sinus openings and passages ■ promotes sinus drainage ■ helps clear nasal passages ■ temporarily reduces fever   

SPL UNCLASSIFIED SECTION

SINUS + HEADACHE NIGHT

Drug Facts

OTC - PURPOSE SECTION

Uses

■ temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:    ■ headache    ■ sinus congestion and pressure    ■ nasal congestion    ■ runny nose and sneezing    ■ minor aches and pains ■ helps decongest sinus openings and passages ■ promotes sinus drainage ■ helps clear nasal passages ■ temporarily reduces fever

Warnings

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

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

■ 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

■ 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

Ask a doctor or pharmacist before use if you are

■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers

When using this product

■ do not exceed recommended dosageIn addition, when using Sinus + Headache Night:■ excitability may occur, especially in children ■ drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

■ 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

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.

Directions

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

■ do not take Day and Night caplets at the same time ■ do not take more than a total of 10 caplets in 24 hours

Other information

■ store between 20-25ºC (68-77ºF) in a dry place ■ retain carton for complete product information and warnings

Inactive ingredients

SINUS + HEADACHE DAY

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide

SINUS + HEADACHE NIGHT

acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide