Leader Severe Sinus Congestion

Cardinal Health

Cardinal Health Severe Sinus Congestion Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each capsule)
• Purposes
• Leader Severe Sinus Congestion Uses
• Warnings
• Do not use
• Ask a doctor before use if you have
• Ask a doctor or pharmacist before use if you are
• When using this product
• Stop use and ask a doctor if
• If pregnant or breast-feeding,
• Keep out of reach of children.
• Directions
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Leader Severe Sinus Congestion Uses

• •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• •runny nose
• •sneezing
• •itching of the nose or throat
• •itchy, watery eyes
• •temporarily relieves these symptoms due to a cold:
• •nasal congestion
• •sinus congestion and pressure
• •headache
• •minor aches and pains
• •cough
• •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 capsules (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

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
• •in children under 12 years of age
• •to make a child sleepy

Ask a doctor before use if you have

• •liver disease
• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •glaucoma
• •cough with excessive phlegm (mucus)
• •a breathing problem such as emphysema or chronic bronchitis
• •difficulty in urination due to enlargement of the prostate gland
• •persistent or chronic cough such as occurs with smoking, asthma, or emphysema

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 dosage
• •may cause marked drowsiness
• •avoid alcoholic drinks
• •alcohol, sedatives, and tranquilizers may increase drowsiness
• •be careful when driving a motor vehicle or operating machinery
• •excitability may occur, especially in children

Stop use and ask a doctor if

• •pain, cough, 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
• •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• •nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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)
• •adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
• •children under 12 years: do not use

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Alka-Seltzer Plus® Severe Sinus Congestion active ingredients

Severe Sinus Congestion

Acetaminophen – Pain Reliever / Fever Reducer

Dextromethorphan Hydrobromide – Cough Suppressant

Doxylamine Succinate – Antihistamine

Phenylephrine Hydrochloride – Nasal Decongestant

Allergy & Cough Formula

Sinus Congestion & Pressure – Headache & Pain

Runny Nose & Sneezing – Itchy, Watery Eyes – Cough

20 LIQUID GELS (LIQUID FILLED CAPSULES)