THERAFLU MULTI SYMPTOM SEVERE COLD
Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 500mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6426
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.
Acetaminophen, 500 mg
Dextromethorphan hydrobromide, 20 mg
Phenylephrine hydrochloride, 10 mg
Pain reliever / fever reducer
Cough suppressant
Nasal decongestant
- 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
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.
- 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.
- 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
- taking the blood thinning drug warfarin
- do not exceed recommended dosage
- 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.
ask a health care professional before use.
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.
- 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.
- 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.
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
call 1-800-452-0051
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
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org
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
| THERAFLU
MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution |
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| Labeler - Novartis Consumer Health, Inc. (879821635) |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.



