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Contac Cold and Flu Night

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Meda Consumer Healthcare Inc.
NDC Code: 46017-022

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 2 mg

Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • headache
  • runny nose
  • sore throat
  • minor aches and pains
  • sneezing
  • 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, occurs with or is 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

  • diabetes
  • liver disease
  • heart disease
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • 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
 ■  taking sedatives or tranquilizers

When using this product
 ■  do not exceed recommended dosage
 ■  drowsiness may occur
 ■  avoid alcoholic drinks
 ■  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
 ■  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
 ■  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:

corn starch, D&C yellow No. 10 aluminum lake, FD&C Yellow No. 6 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions or comments?

call toll-free 1-855-874-0970 (English/Spanish) weekdays

                                          

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

NIGHT

CONTAC®
COLD+FLU


Phenylephrine, Acetaminophen, Chlorpheniramine
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine


Maximum Strength
Multi-Symptom


Nasal Congestion + Sinus Pressure
Sore Throat + Head & Body Aches
Fever + Runny Nose + Sneezing


24 Night Caplets


CONTAC®
COLD+FLU
NIGHT
Restful 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.
Atlanta, GA 30339
CONTAC® is a registered trademark of Meda AB
© Meda AB 2014
Made in Canada
www.contac.com

CONTAC COLD AND FLU  NIGHT
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-022
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
STARCH, CORN 
ALUMINUM OXIDE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL  
POTASSIUM SORBATE 
POVIDONE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize21mm
FlavorImprint Codemoon;symbol
Contains    
Packaging
#Item CodePackage Description
1NDC:46017-022-242 BLISTER PACK in 1 CARTON
1NDC:46017-022-9912 TABLET in 1 BLISTER PACK
2NDC:46017-022-022 TABLET in 1 PACKAGE
3NDC:46017-022-044 TABLET in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2014
Labeler - Meda Consumer Healthcare Inc. (831410522)

Revised: 06/2014
 
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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