Leader Severe Cold and Flu

Cardinal Health

Cardinal Health Severe Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Leader Severe Cold and Flu 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
• Leader Severe Cold and Flu Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Leader Severe Cold and Flu Uses

• •for the temporary relief of the following cold/flu symptoms:
• •minor aches and pains
• •nasal congestion
• •sore throat
• •headache
• •cough
• •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

Sore throat warning: 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.

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

• •heart disease
• •high blood pressure
• •thyroid disease
• •diabetes
• •liver disease
• •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)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

• •nervousness, dizziness or sleeplessness occur
• •new symptoms occur
• •pain, nasal congestion or cough gets worse or lasts more than 7 days
• •redness or swelling is present
• •fever gets worse or lasts more than 3 days
• •cough comes back or occurs with rash or headache that lasts
  •  These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

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

Leader Severe Cold and Flu Other information

• •each caplet contains: sodium 3 mg

Inactive ingredients

acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Cold & Flu Severe active ingredients

For Adults

Severe Cold & Flu

Pain Reliever / Fever Reducer – Acetaminophen

Nasal Decongestant – Phenylephrine HCl

Cough Suppressant – Dextromethorphan HBr

Expectorant – Guaifenesin

Daytime

Non-Drowsy

Severe

Headache, Fever, Sore Throat, Nasal Congestions, Cough, Chest Congestion, Clears out mucus

24 CAPLETS