Theraflu

Novartis Consumer Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• Theraflu Uses
• Warnings
• Do Not Use
• Ask a doctor before use if you have
• Ask Doctor or Pharmacist before use if you have
• When using this product
• Stop Use and ask a doctor if
• If pregnant or breast-feeding,
• Keep Out of Reach of Children
• Directions
• Other Information
• Inactive ingredients
• Questions or comments?
• Additional information listed on other panels
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Theraflu Uses

• temporarily relieves
  • minor aches and pains
  • itchy nose or throat
  • minor sore throat pain
  • sneezing
  • runny nose
  • headache
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • nasal and sinus congestion
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets in 24 hours, which is the maximum daily amount
• 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

• in a child under 4 years of age
• if you are allergic to acetaminophen
• 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask Doctor or Pharmacist before use if you have

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness
• excitability may occur, especially in children

Stop Use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health care professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• take every 4 hours, while symptoms persist
• do not take more than 12 caplets in 24 hours

Other Information

• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acacia, benzoic acid, FD&C blue #2 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavor, hypromellose, magnesium stearate, menthol, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, pregelatinized starch, propylene glycol, stearic acid, sucralose, titanium dioxide

Questions or comments?

call 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2009

www.theraflu.com

Additional information listed on other panels

Distributed by: Novartis Consumer Health, Inc .
Parsippany, NJ 07054-0622 ©20##

www.theraflu.com

Principal Display Panel

NDC 0067-6437-24

Theraflu® Warming Relief
Nighttime Multi-Symptom Cold Caplets

ACETAMINOPHEN - PAIN RELIEVER - FEVER REDUCER /
CHLORPHENIRAMINE MALEATE - ANTIHISTAMINE /
DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT /
PHENYLEPHRINE HCl - NASAL DECONGESTANT

• Nasal Congestion
• Cough
• Sore Throat Pain
• Runny Nose
• Headache
• Body Ache
• Sneezing
• Fever

24 Coated Caplets