CONTAC COLD AND FLU DAY NIGHT- acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride 
Mylan 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

Active ingredients for Night Formula (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
minor aches and pains
stuffy nose
sinus congestion and pressure
sore throat
fever
sneezing (Night formula only)
runny nose (Night formula only)

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

liver disease
heart disease
thyroid disease
trouble urinating due to an enlarged prostate gland
diabetes
high blood pressure
glaucoma (Night formula only)
a breathing problem such as emphysema or chronic bronchitis (Night formula only)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers (Night formula only)

When using this product

■ do not exceed recommended dosage
■ for Night formula only:
   ■ 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 last 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 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 at 20°-25°C (68°-77°F)

 

Inactive ingredients for Day Formula only: corn starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.

Inactive ingredients for Night Formula only: 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 Day Night Caplets: 28 count Package

DAY NIGHT

CONTAC®
COLD+FLU

Phenylephrine, Acetaminophen,Chlorpheniramine*
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine (*Night formula only)

Maximum Strength
Multi-Symptom

Nasal Congestion + Sinus Pressure
Sore Throat + Head & Body Aches + Fever
Night formula only: Runny Nose + Sneezing

16 Day Caplets
12 Night Caplets

CONTAC®
COLD+FLU
Non-Drowsy Relief
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

Display Panel CONTAC Cold +Flu Day Night Caplets 28 count Carton
CONTAC COLD AND FLU  DAY NIGHT
acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-020
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-020-281 in 1 CARTON; Type 0: Not a Combination Product07/01/201401/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 16 
Part 21 BLISTER PACK 12 
Part 1 of 2
CONTAC COLD AND FLU  DAY
acetaminophen and phenylephrine hydrochloride tablet
Product Information
Item Code (Source)NDC:46017-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code sun;symbol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-021-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201401/01/2020
Part 2 of 2
CONTAC COLD AND FLU  NIGHT
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
Product Information
Item Code (Source)NDC:46017-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code moon;symbol
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-022-9912 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201401/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201401/01/2020
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 6/2014
 
Mylan Consumer Healthcare, Inc.