Theraflu

Novartis Consumer Health

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient(s)
• Purpose
• Use(s)
• 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
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient(s)

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/ fever reducer
Expectorant
Nasal decongestant

Use(s)

• for the temporary relief of:
• minor aches and pains
• headache
• minor sore throat pain
• nasal and sinus congestion
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive 

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.

Ask a doctor before use if you have

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

• 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
• 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
• symptoms do not improve within 7 days or accompanied by fever
• 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 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 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 contains: potassium 5 mg, sodium 9 mg

• store at controlled room temperature 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

acesulfame K, benzyl alcohol, citric acid, edetate disodium, FD&C yellow #6, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

call 1-800-452-0051

Additional information listed on other panels

DO NOT USE IF NECKBAND PRINTED WITH “NOVARTIS” IS TORN OR MISSING

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

Principal Display Panel

NDC 0043-6296-

Theraflu®
Warming Relief
Cold & Chest Congestion

ACETAMINOPHEN - PAIN RELIEVER / FEVER REDUCER
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl - NASAL DECONGESTANT NON-DROWSY

• Thins & Loosens Mucus
• Nasal & Sinus Congestion
• Body Ache
• Sore Throat
• Headache
• Fever

Orange Flavor

8.3 FL OZ (245.5 mL)