CONTAC COLD AND FLU NIGHT- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet

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]

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

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

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 DOCTOR

Ask a doctor before use if you have

• diabetes
• liver disease
• heart disease
• glaucoma
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• thyroid disease
• a breathing problem such as emphysema or chronic bronchitis

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
   taking the blood thinning drug warfarin
   taking sedatives or tranquilizers

WHEN USING

When using this product
   do not exceed recommended dosage
   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

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 hours.
• children under 12 years of age: ask a doctor.

Other information

store at 20°-25°C (68°-77°F)

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

PRINCIPAL DISPLAY PANEL

                                          

Display Panel CONTAC Cold+Flu Night Caplets: 24 count Package

NIGHT

CONTAC®
COLD+FLU

Phenylephrine HCl, Acetaminophen, Chlorpheniramine Maleate
Nasal Decongestant/Pain Reliever-Fever Reducer/Antihistamine

See new warning

Maximum Strength
Multi-Symptom

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

24 CAPLETS

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:
Mylan Consumer Healthcare, Inc.,
Morgantown, WV 26505 Made in Canada
CONTAC® is a registered trademark of Meda AB, a Mylan Company
© Mylan, Inc.
www.contac.com UC402324-06-03

INGREDIENTS AND APPEARANCE

CONTAC COLD AND FLU  NIGHT
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-022
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	moon;symbol
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-022-24	2 in 1 CARTON	07/01/2014
1	NDC: 46017-022-99	12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 46017-022-02	2 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2014
3	NDC: 46017-022-04	4 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2014

Labeler - Mylan Consumer Healthcare, Inc. (831410522)