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Contac Cold and Flu Maximum Strength

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Meda Consumer Healthcare Inc.
NDC Code: 46017-023

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 ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2mg

Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses
  • temporarily relieves these symptoms due to the common cold or flu:
    • nasal congestion
    • headache
    • minor aches and pains
    • runny nose
    • sneezing
    • sore throat
  • temporarily reduces fever

Warnings

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

  • more than 8 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, ask a doctor promptly.

Do not use

  • 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
  • glaucoma
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • 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
  • you get nervous, dizzy, or sleepless
  • any new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 caplets every 6 hours as needed.
  • Do not take more than 8 caplets in 24 hours.
  • children under 12 years of age: ask a doctor

Other information
  • store at 20° - 25°C (68°- 77°F)

Inactive ingredients

carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, starch, stearic acid, talc, titanium dioxide

Questions or comments? call toll-free 1-855-874-0970 (English/Spanish), weekdays

Display Panel CONTAC Maximum Strength Cold + Flu: 24 ct Package

MAXIMUM STRENGTH

CONTAC®
COLD+FLU

NASAL DECONGESTANT/PAIN RELIEVER – FEVER REDUCER/ANTIHISTAMINE

RELIEF OF:

  • NASAL CONGESTION -> Phenylephrine
  • HEADACHES, SORE THROAT, FEVER -> Acetaminophen
  • RUNNY NOSE, SNEEZING -> Chlorpheniramine

NET CONTENTS:
24 CAPLETS

See new warnings information.

MAXIMUM STRENGTH
CONTAC®
COLD+FLU

TAMPER EVIDENT FEATURES: This product is protected in a
sealed blister. Do not use if blister or printed foil is broken.
Distributed by:
Meda Consumer Healthcare Inc.
Marietta, GA 30062
CONTAC® is a registered trademark of Meda AB
© Meda AB 2011 www.contac.com

CONTAC COLD AND FLU  MAXIMUM STRENGTH
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-023
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize23mm
FlavorImprint CodeL223
Contains    
Packaging
#Item CodePackage Description
1NDC:46017-023-242 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2011
Labeler - Meda Consumer Healthcare Inc. (831410522)

Revised: 07/2011
 
Meda Consumer Healthcare 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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