PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display NDC 0067-7918-06 THERAFLU NIGHTTIME SEVERE COLD & COUGH ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT NASAL CONGESTION SORE THROAT PAIN COUGH HEADACHE BODY ACHE FEVER RUNNY NOSE SNEEZING Honey Lemon Infused with Chamomile & White Tea Flavors 6 PACKETS Theraflu provides powerful relief from your severe cold and flu symptoms. www.theraflu.com READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. 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 2015 46150743

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each packet) Acetaminophen, 650 mg Diphenhydramine HCl, 25 mg Phenylephrine HCl, 10 mg

INDICATIONS & USAGE SECTION.


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

DOSAGE & ADMINISTRATION SECTION.


Directions do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use 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.

INACTIVE INGREDIENT SECTION.


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

STORAGE AND HANDLING SECTION.


Other information each packet contains: potassium 10 mg, sodium 23 mg phenylketonurics: contains phenylalanine 13 mg per packet store at controlled room temperature 20-25C (68-77F). Protect product from heat and moisture.

OTC - QUESTIONS SECTION.


Questions or Comments? call 1-800-452-0051

WARNINGS SECTION.


Warnings Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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 12 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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, 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 taking 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 pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with 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.

OTC - PURPOSE SECTION.


Purposes Pain reliever / fever reducer Antihistamine / cough suppressant Nasal decongestant