CONTAC COLD AND FLU DAY NIGHT- acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride
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.
----------
Drug Facts
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.
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
- •
- trouble urinating due to an enlarged prostate gland
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.
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
Inactive ingredients
corn starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.
Active ingredients (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg
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.
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
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.
Display Panel CONTAC Cold+Flu Day Night Caplets: 28 count Package
NDC 46017-025-28
CONTAC®
COLD + FLU See 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.com UC402528-06-03
| CONTAC COLD AND FLU
DAY NIGHT
acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Mylan Consumer Healthcare, Inc. (831410522) |