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 (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant

Theraflu Uses

  • temporarily relieves
    • minor aches and pains
    • itchy nose or throat
    • minor sore throat pain
    • sneezing
    • runny nose
    • headache
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation as may occur with a cold
    • nasal and sinus congestion
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 12 caplets 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 a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask Doctor or Pharmacist before use if you have

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

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 a 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, while symptoms persist
  • do not take more than 12 caplets in 24 hours

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

2 caplets

Other Information

  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acacia, benzoic acid, FD&C blue #2 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavor, hypromellose, magnesium stearate, menthol, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, pregelatinized starch, propylene glycol, stearic acid, sucralose, titanium dioxide

Questions or comments?

call 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2009

www.theraflu.com

Additional information listed on other panels

PARENTS: Learn about teen medicine abuse.

www.StopMedicineAbuse.org

TAMPER EVIDENT UNIT

DO NOT USE IF FOIL SEAL IS TORN OR BROKEN

Distributed by: Novartis Consumer Health, Inc .
Parsippany, NJ 07054-0622 ©20##

www.theraflu.com

Principal Display Panel

NDC 0067-6437-24

Theraflu® Warming Relief
Nighttime Multi-Symptom Cold Caplets

ACETAMINOPHEN - PAIN RELIEVER - FEVER REDUCER /
CHLORPHENIRAMINE MALEATE - ANTIHISTAMINE /
DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT /
PHENYLEPHRINE HCl - NASAL DECONGESTANT

  • Nasal Congestion
  • Cough
  • Sore Throat Pain
  • Runny Nose
  • Headache
  • Body Ache
  • Sneezing
  • Fever

24 Coated Caplets

Theraflu

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephreine HCI TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6395
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
MENTHOL
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYSORBATE 60
polysorbate 80
STARCH, CORN
propylene glycol
STEARIC ACID
Sucralose
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED (Red) 18 mm Cx;N CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:0067-6395-24 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-09-02


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