Theraflu

Novartis Consumer Health

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
• 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 1000 mg
Guaifenesin 400 mg

Purpose

Pain reliever / fever reducer
Expectorant

Theraflu Uses

• temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • headache
  • minor sore throat pain
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

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

• more than 4 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.

Ask Doctor before use if you have

• liver disease
• 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

Stop use and ask a doctor if

• pain or cough 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 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 6 hours; do not take more than 4 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 15 mg
• phenylketonurics : contains phenylalanine 24 mg per packet
• store at controlled room temperature 20-25°C (68-77°F).

Inactive ingredients

acesulfame K, aspartame, citric acid, D&C yellow #10, 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

TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU^® PACKET IS TORN OR BROKEN.

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

www.theraflu.com

Principal Display

•  NDC 0043-0483-06

Theraflu®
Flu & Chest Congestion

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
GUAIFENESIN - EXPECTORANT

• Chest Congestion
• Sore Throat
• Headache
• Body Ache
• Fever

Natural Citrus Flavor

6 Packets