NDC 46017-022 Contac Cold And Flu Night
Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride Tablet Oral

Product Information

Product Code46017-022
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Contac Cold And Flu Night
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Mylan Consumer Healthcare, Inc.
Labeler Code46017
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
part341
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-01-2014
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
10-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)YELLOW (C48330)
ShapeCAPSULE (C48336)
Size(s)21 MM
Imprint(s)MOON;SYMBOL
Score1

Product Packages

NDC 46017-022-02

Package Description: 2 TABLET in 1 PACKAGE

NDC 46017-022-04

Package Description: 4 TABLET in 1 PACKAGE

NDC 46017-022-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 TABLET in 1 BLISTER PACK (46017-022-99)

Product Details

Contac Cold And Flu Night is a human over the counter drug product labeled by Mylan Consumer Healthcare, Inc.. The generic name of Contac Cold And Flu Night is acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride. The product's dosage form is tablet and is administered via oral form.


What are Contac Cold And Flu Night Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Chlorpheniramine

Chlorpheniramine is pronounced as (klor fen ir' a meen)
Why is chlorpheniramine medication prescribed?
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine he...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Contac Cold And Flu Night Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


Otc - 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.


Otc - 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

Otc - Ask Doctor/Pharmacist



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


Otc - 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


Otc - 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.


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


Package Label.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


* Please review the disclaimer below.