CONTAC COLD AND FLU MAXIMUM STRENGTH- 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 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:
o
nasal congestion
o
headache
o
minor aches and pains
o
runny nose
o
sneezing
o
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 Maximum Strength Cold + Flu:  24 ct Package
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 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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
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)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize23mm
FlavorImprint Code L223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-023-242 in 1 CARTON07/15/201101/01/2020
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/201101/01/2020
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 7/2011
 
Mylan Consumer Healthcare, Inc.