Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure11 sections
Indications and 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
Dosage and administration
■ 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 adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years ask a doctor
Storage and handling
■ store between 20-25ºC (68-77ºF) in a dry place ■ retain carton for complete product information and warnings
■ 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 - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
Active ingredients (in each night caplet)
Purpose
Acetaminophen 325 mg
Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg
Antihistamine
Phenylephrine HCl 5 mg
Nasal decongestant
Uses
INDICATIONS & USAGE SECTION
■ 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
WARNINGS SECTION
Liver warning
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
When using this product
OTC - WHEN USING SECTION
■
do not exceed recommended dosage In 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
OTC - STOP USE SECTION
■ 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
■
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
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole; do not crush, chew, or dissolve
children under 12 years
ask a doctor
Other information
STORAGE AND HANDLING SECTION
■ store between 20-25ºC (68-77ºF) in a dry place
■ retain carton for complete product information and warnings
Inactive ingredients
INACTIVE INGREDIENT SECTION
SINUS + HEADACHE DAY
SPL UNCLASSIFIED SECTION
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
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