Contac cold and fluday night kit

Day

Active ingredients (in each caplet)

Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer
Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sore throat
  • fever
  • sinus congestion and pressure

Warnings

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

  • more than 4000 mg of acetaminophen in 24 hrs, 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.

Otc - do not use section

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.

Otc - ask doctor section

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin.

Otc - when using section

When using this product do not exceed recommended dosage.

Otc - stop use section

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.

Otc - pregnancy or breast feeding section

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 yrs of age and over: take 2 caplets every 6 hours as needed.
  • do not take more than 8 caplets in 24 hrs.
  • children under 12 yrs of age: ask a doctor

Other information

store at 20-25C (68-77F)

Inactive ingredient section

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

Night

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
  • sneezing
  • headache
  • runny nose
  • fever
  • sore throat
  • minor aches and pains

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

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • 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
  • 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 effect
  • 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 hrs.
  • children under 12 years of age: ask a doctor

Other information

store at 20-25C (68-77F)

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

Retain outer carton for complete directions and warnings.

Ingredients and appearance - Product information

Contac cold and fluday night kit- Acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 46017-025
Route of Administration Oral

Product Characteristics

Color YELLOW Size 21 mm
Shape CAPSULE Score 1
Imprint Code moon;symbol

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Mylan Consumer Healthcare, Inc.( 831410522)

Package label.principal display panel

Display Panel CONTAC Cold+Flu Day Night Caplets: 28 count Package

NDC 46017-025-28

CONTAC ®
COLD + FLUSee new warning

DAY

Acetaminophen -
Pain reliever/Fever reducer
Phenylephrine hydrochloride -
Nasal decongestant

Head & Body Aches
Fever Sore Throat
Nasal Congestion
Sinus Pressure

16 CAPLETS

NIGHT

Acetaminophen -
Pain reliever/Fever reducer
Chlorpheniramine maleate Antihistamine
Phenylephrine hydrochloride -
Nasal decongestant

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

12 CAPLETS

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.contac.comUC402528-06-03