Theraflu

Novartis Consumer Health
Novartis Consumer Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Theraflu Uses
• Warnings
• Do not use
• Ask Doctor before use if you have
• Ask a doctor or pharmacist before use if you are taking
• When using this product
• Stop use and ask a doctor if
• If pregnant or breast- feeding,
• Keep Out of Reach of Children
• Directions
• Theraflu Other information
• Inactive ingredients
• Questions or Comments?
• Additional Information Listed On Other Panels
• Principal Display

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen, 650 mg

Diphenhydramine hydrochloride, 25 mg

phenylephrine hydrochloride, 10 mg

Purpose

Pain reliever / fever reducer

Antihistamine / cough suppressant

Nasal decongestant

Theraflu Uses

• temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • runny nose or throat
  • itchy, watery eyes due to hay fever
  • cough due to minor throat and bronchial irritation
• temporarily reduces fever

Warnings

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

• more than 6 packets 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 a pharmacist.
• with any other product containing diphenhydramine, even one used on the skin
• 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 Doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• avoid alcoholic drinks
• marked drowsiness may occur
• 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

• nervousness, dizziness, or sleeplessness occurs
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• symptoms do not get better or worsen
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs with fever, rash or headache that lasts. There 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; do not take more than 6 packets in 24 hours unless directed by a doctor

• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Theraflu Other information

• each packet contains: potassium 10 mg, sodium 23 mg
• phenylketonurics : contains phenylalanine 13 mg per packet
• store at controlled room temperature 20 -25^oC (68-77^oF). Protect from excessive heat and moisture.

Inactive ingredients

acesulfame K, aspartame, citric acid, D&C yellow#10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or Comments?

call 1-800-452-0051

Additional Information Listed On Other Panels

Theraflu®

Nighttime

Severe Cold & Cough

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

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

Principal Display