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THERAFLU MAX-D (acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl) powder, for solution
[Novartis Consumer Health, Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Active ingredient (in each packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 mg

Guaifenesin 400 mg

Pseudoephedrine HCl 60 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains headache minor sore throat pain cough
    • nasal congestion helps decongest sinus openings and passages
  • 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 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
  • diabetes
  • thyroid disease
  • high blood pressure
  • 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, chronic bronchitis, or emphysema

Ask a doctor or a pharmacist

  • taking the blood thinning drug warfari

When using this product

  • do not exceed recommended dosage

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion 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

 

AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and overone 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: calcium 10 mg, potassium 10 mg, sodium 15 mg
  • phenylketonurics: contains phenylalanine 23.6 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

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INGREDIENTS & APPEARANCE

THERAFLU  MAX-D
acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-6427
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN1000 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM CITRATE 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6427-066 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34108/01/2010
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIBusiness Operations
Novartis Consumer Health129836151ANALYSIS, MANUFACTURE

Revised: 6/2010
 
Novartis Consumer Health, Inc.