THERAFLU description, usages, side effects, indications, overdosage, supplying and lots more!

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THERAFLU

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen, 500 mg

Dextromethorphan hydrobromide, 20 mg

Phenylephrine hydrochloride, 10 mg

Purpose

Pain reliever / fever reducer

Cough suppressant

Nasal decongestant

THERAFLU 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.

THERAFLU 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

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

Principal Display

THERAFLU

THERAFLU

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6426
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ASPARTAME
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
maltodextrin
SILICON DIOXIDE
SODIUM CITRATE
SUCROSE
TRIBASIC CALCIUM PHOSPHATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-6426-06 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-12-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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