Theraflu

Novartis Consumer Health

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablespoonful, 15 mL)
• Purpose
• Theraflu 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
• Theraflu Other information
• Inactive Ingredients
• Questions or Comments?
• Additional information listed on other panels
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablespoonful, 15 mL)

Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant/antihistamine
Nasal decongestant

Theraflu Uses

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

Warnings

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

• more than 6 doses (12 tablespoonfuls or 180 mL) 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.
• with any other drug containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• 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
• 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 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, in dose cup provided, while symptoms persist
• do not take more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours

Theraflu Other information

• each tablespoonful (15 mL) contains: potassium 5 mg, sodium 7 mg
• store at controlled room temperature 20-25C (68-77F)

Inactive Ingredients

acesulfame K, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or Comments?

call 1-800-452-0051

Additional information listed on other panels

TAMPER EVIDENT INNER UNIT
DO NOT USE IF NECKBAND PRINTED WITH “NOVARTIS” IS TORN OR MISSING

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

www.theraflu.com

Package/Label Principal Display Panel

See New Warnings Information

NDC 0043-0460-08

Theraflu®
Warming Relief
Nighttime
Severe Cold & Cough

ACETAMINOPHEN - PAIN RELIEVER / FEVER REDUCER
DIPHENHYDRAMINE HCl – COUGH SUPPRESSANT/ ANTIHISTAMINE
PHENYLEPHRINE HCl – NASAL DECONGESTANT

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

Alcohol content: 10%

Cherry Flavor

8.3 FL OZ (245.5 mL)