THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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Drug Facts
Active ingredients (in each packet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
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
Warnings
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
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.
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 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 a 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 last more than 7 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- do not use more than directed
- take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor
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- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer 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.
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°C (68-77°F). Protect product from heat and moisture.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow no. 6, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate
Principal Display Panel
NDC 0067-8124-06
THERAFLU ®
NIGHTTIME
MULTI-SYMPTOM
SEVERE COLD
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
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 YOU USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN.
Lipton is a registered trademark of the Unilever Group of Companies and is used under license.
Distributed by: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
©2015
Made in Canada
12211
| THERAFLU NIGHTTIME MULTI-SYMPTOM SEVERE COLD POWDER
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| GSK Consumer Health, Inc. | 129836151 | manufacture(0067-8124) , analysis(0067-8124) , pack(0067-8124) , label(0067-8124) | |