Contac Cold and Flu by Mylan Consumer Healthcare, Inc. Drug Facts
Contac Cold and Flu by
Drug Labeling and Warnings
Contac Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Mylan Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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.
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Drug Facts
Active ingredients for Day Formula (in each caplet)
Acetaminophen 500 mg
Phenylephrine hydrochloride 5 mg
Active ingredients for Night Formula (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 2 mg
Phenylephrine hydrochloride 5 mg
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- headache
- minor aches and pains
- stuffy nose
- sinus congestion and pressure
- sore throat
- fever
- sneezing (Night formula only)
- runny nose (Night formula only)
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
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- diabetes
- high blood pressure
- glaucoma (Night formula only)
- a breathing problem such as emphysema or chronic bronchitis (Night formula only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Night formula only)
When using this product
■ do not exceed recommended dosage
■ for Night formula only:
■ drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ 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 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 appear
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
Inactive ingredients for Day Formula only: corn starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.
Inactive ingredients for Night Formula only: 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.
Display Panel CONTAC Cold+Flu Day Night Caplets: 28 count Package
DAY NIGHT
CONTAC®
COLD+FLU
Phenylephrine, Acetaminophen,Chlorpheniramine*
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine (*Night formula only)
Maximum Strength
Multi-Symptom
Nasal Congestion + Sinus Pressure
Sore Throat + Head & Body Aches + Fever
Night formula only: Runny Nose + Sneezing
16 Day Caplets
12 Night Caplets
CONTAC®
COLD+FLU
Non-Drowsy Relief
Restful 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
CONTAC® is a registered trademark of Meda AB
© Meda AB 2014 Made in Canada
www.contac.com
| CONTAC COLD AND FLU
DAY NIGHT
acetaminophen and phenylephrine hydrochloride/ acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride kit |
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| Labeler - Mylan Consumer Healthcare, Inc. (831410522) |