Contac Cold and Flu Day by Meda Consumer Healthcare Inc. Drug Facts

Contac Cold and Flu Day by

Drug Labeling and Warnings

Contac Cold and Flu Day by is a Otc medication manufactured, distributed, or labeled by Meda Consumer Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CONTAC COLD AND FLU DAY NIGHT- 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 (in each caplet)

Acetaminophen 500 mg

Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer

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

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               ■ trouble urinating due to an enlarged prostate gland
    ■  diabetes                  ■ high blood pressure              
    ■  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
    ■ 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 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, 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, Acetaminophen
Nasal Decongestant/Pain Reliever-Fever Reducer

Maximum Strength
Multi-Symptom

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

24 Day Caplets

CONTAC®
COLD+FLU
DAY
Non-Drowsy 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, Made in Canada
    CONTAC ® is a registered trademark of Meda AB
    © Meda AB 2014 www.contac.com
Display Panel CONTAC Cold + Flu Day Caplets: 24 count Carton
CONTAC COLD AND FLU DAY NIGHT 
acetaminophen and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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: 46017-021-081 in 1 CARTON07/01/201401/01/2020
1NDC: 46017-021-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 46017-021-243 in 1 CARTON07/01/201401/01/2020
2NDC: 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
Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 6/2014
 
Mylan Consumer Healthcare, Inc.