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Theraflu Cold and Sore Throat

Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 325mg, PHENIRAMINE MALEATE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6716

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, 325 mg
Pheniramine maleate, 20 mg
Phenylephrine hydrochloride, 10 mg

Purpose

Pain reliever / fever reducer
Antihistamine
Nasal decongestant

Uses
  • temporarily relieves these symptoms due to a cold:
    • minor 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 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, 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
  • thyroid disease
  • high blood pressure
  • glaucoma
  • diabetes
  • 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 taking
  • the blood thinning drug warfarin
  • sedatives or tranquilizers

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.

Other information
  • each packet contains: sodium 44 mg
  • store at controlled room temperature 20-25°C (68-77°F).

Inactive ingredients

acesulfame K, citric acid, D&C yellow #10, FD&C yellow #6, flavors, magnesium stearate, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, 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 0067-6716-06

Theraflu®
Cold & 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 Lemon Flavor

6 Packets

THERAFLU  COLD AND SORE THROAT
acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6716
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM CITRATE 
LECITHIN, SOYBEAN 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-6716-066 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/27/2005
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 07/2013
 
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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