Package Insert and Label Information: THERAFLU MULTI SYMPTOM SEVERE COLD
THERAFLU MULTI SYMPTOM SEVERE COLD- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride powder, for solution
Novartis Consumer Health, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient
Acetaminophen, 500 mg
Dextromethorphan hydrobromide, 20 mg
Phenylephrine hydrochloride, 10 mg
Purpose
Pain reliever / fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold:
• minor aches and pains • minor sore throat pain
• headache • nasal and sinus congestion
• 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 6 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, as a doctor or a 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 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 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 occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- symptoms do not get better or worsen
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- 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 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor
| Age | Dose |
| children under 4 years of age | do not use |
| children 4 to under 12 years of age | do not use unless directed by a doctor |
| adults and children 12 years of age and over | one packet |
- 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.
Other information
- each packet contains: potassium 10 mg, sodium 19 mg
- phenylketonurics: contains phenylalanine 20 mg per packet
- store at controlled room temperature 20-25°C (68-77°F). Protect from excessive heat and moisture.
Inactive ingredients
acesulfame K, aspartame, citric acid, D&C yellow #10, FD&C blue #1, 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
Theraflu®
Multi-Symptom
Severe Cold
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
- Nasal Congestion
- Cough
- Body Ache
- Sore Throat Pain
- Fever
- Headache
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
| THERAFLU
MULTI SYMPTOM SEVERE COLD acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution | ||||||||||||||||||||||||||
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| Labeler — Novartis Consumer Health, Inc. (879821635) |
Revised: 01/2011 Novartis Consumer Health, Inc.
