CONTAC COLD AND FLU NIGHT- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet 
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 (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Phenylephrine hydrochloride 5 mg

Purposes

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 4000 mg of acetaminophen 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

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 HCl, Acetaminophen, Chlorpheniramine Maleate
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine

See new warning

Maximum Strength
Multi-Symptom

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

24 CAPLETS

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:
Mylan Consumer Healthcare, Inc.,
Morgantown, WV 26505 Made in Canada
CONTAC® is a registered trademark of Meda AB, a Mylan Company
© Mylan, Inc.
www.contac.com UC402324-06-03

Contac Cold and Flu Night
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 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)  
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:46017-022-242 in 1 CARTON07/01/201410/31/2022
1NDC:46017-022-9912 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:46017-022-022 in 1 PACKAGE; Type 0: Not a Combination Product07/01/201410/31/2022
3NDC:46017-022-044 in 1 PACKAGE; Type 0: Not a Combination Product07/01/201410/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/201410/31/2022
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 1/2020
 
Mylan Consumer Healthcare, Inc.