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 packet)

Acetaminophen, 650 mg
Pheniramine maleate, 20 mg
Phenylephrine hydrochloride, 10 mg

Purpose

Pain reliever / fever reducer
Antihistamine
Nasal decongestant

Theraflu Uses

  • temporarily relieves these symptoms due to a cold:
    • aches and pains
    • headache
    • minor sore throat pain
    • nasal congestion
  • temporarily reduces fever
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny minor nose
    • sneezing
    • itchy nose and throat
    • itchy, watery eyes

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, ask 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
  • glaucoma
  • a breathing problem such as emphysema, or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

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

Stop use and ask a doctor if

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

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

Inactive ingredients

acacia, acesulfame K, citric acid, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, lecithin, maltodextrin, medium chain triglycerides, mono & diglycerides, silicon dioxide, sodium chloride, sodium citrate, sucrose, triacetin, tribasic calcium phosphate

Questions or Comments?

call 1-800-452-0051

Additional Information Listed On Other Panels

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

  •  NDC 0067-7916-06

Theraflu®
Flu & Sore Throat

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
PHENIRAMINE MALEATE – ANTIHISTAMINE
PHENYLEPHRINE HCl – NASAL DECONGESTANT

  • Sore Throat
  • Nasal Congestion
  • Runny Nose
  • Headache
  • Body Ache
  • Fever

Natural Apple Cinnamon Flavor

6 Packets

Theraflu

Acetaminophen, Pheniramine Maleate, Phenylephrine HCl POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-7916
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
PHENIRAMINE MALEATE Pheniramine 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
maltodextrin
MEDIUM-CHAIN TRIGLYCERIDES
SILICON DIOXIDE
SODIUM CHLORIDE
SODIUM CITRATE
SUCROSE
LECITHIN, SOYBEAN
triacetin
TRIBASIC CALCIUM PHOSPHATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-7916-06 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2005-05-13


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