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.

Drug Facts

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

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 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 a 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
  • 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.

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

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 product from heat and moisture.

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

Questions or Comments?

call 1-800-452-0051

Principal Display
THERAFLU  MULTI SYMPTOM SEVERE COLD
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6426
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
ASPARTAME 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM CITRATE 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY (Green Tea infused with Honey Lemon) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-6426-066 POWDER, FOR SOLUTION in 1 CARTON
2NDC:0067-6426-1112 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2014
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 10/2014
 
Novartis Consumer Health, Inc.

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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