CONTAC COLD AND FLU DAY- acetaminophen 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 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:
o
nasal congestion
o
headache
o
minor aches and pains
o
stuffy nose
o
sore throat
o
sinus congestion and pressure

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4000 mg 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 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
new symptoms appear

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, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, 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 HCl, Acetaminophen
Nasal Decongestant/Pain Reliever-Fever Reducer

Maximum Strength
Multi-Symptom

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

24 CAPLETS

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

© 2019 Mylan, Inc.

www.contact.com   UC402424-06-03

Contac Cold and Flu Day Carton
CONTAC COLD AND FLU  DAY
acetaminophen and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-024
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code MS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46017-024-081 in 1 CARTON07/01/2011
1NDC:46017-024-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:46017-024-243 in 1 CARTON07/01/2011
2NDC:46017-024-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2011
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 1/2020
Document Id: 5b4a6d0f-618a-4a3c-b711-8ee23ac8c7ef
Set id: 251f2782-e7ae-11e1-aff1-0800200c9a66
Version: 5
Effective Time: 20200115
 
Mylan Consumer Healthcare, Inc.