CONTAC COLD AND FLU DAY- acetaminophen and phenylephrine hydrochloride tablet 
Meda Consumer Healthcare Inc.

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.

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Drug Facts

Active ingredients for Day Formula (in each caplet)

Acetaminophen 500 mg

Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • headache
    • minor aches and pains
    • stuffy nose
    • sore throat
    • sinus congestion and pressure
  • 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 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
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease

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

  • You get nervous, dizzy, or sleepless
  • 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
  • Any new symptoms appear

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 below 25°C (77°F)

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, pregelatinized starch, sodium lauryl sulfate, starch, stearic acid, talc.

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

Display Panel CONTAC Cold + Flu Day Caplets: 24 count Package

DAY

CONTAC®

COLD+FLU


Phenylephrine, Acetaminophen


Maximum Strength

Multi-Symptom


Nasal Congestion + Sinus Pressure +Sore Throat

Head & Body Aches + Fever


24 Day Caplets


CONTAC®

COLD+FLU

DAY

Non-Drowsy Relief

Get Well Soon!


Retain outer carton for complete directions and warnings.


TAMPER-EVIDENT PACKAGING FEATURE: 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, Made in Ireland

CONTAC® is a registered trademark of Meda AB

© Meda AB 2012 www.contac.com

Display Panel CONTAC Cold + FluDay Caplets: 24 count Package

CONTAC COLD AND FLU  DAY
acetaminophen and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46017-024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POTASSIUM SORBATE 
POVIDONE 
STARCH, PREGELATINIZED CORN 
SODIUM LAURYL SULFATE 
STARCH, CORN 
STEARIC ACID 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code MS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-024-081 in 1 CARTON
1NDC:46017-024-998 in 1 BLISTER PACK
2NDC:46017-024-243 in 1 CARTON
2NDC:46017-024-998 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2011
Labeler - Meda Consumer Healthcare Inc. (831410522)

Revised: 2/2013
 
Meda Consumer Healthcare Inc.