Label: CONTAC COLD AND FLU DAY- acetaminophen and phenylephrine hydrochloride tablet

  • NDC Code(s): 46017-024-08, 46017-024-24, 46017-024-99
  • Packager: Mylan Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated January 15, 2020

If you are a consumer or patient please visit this version.

  • Active ingredients for Day Formula (in each caplet)

    Acetaminophen 500 mg

    Phenylephrine hydrochloride 5 mg

  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:
    o
    nasal congestion
    o
    headache
    o
    minor aches and pains
    o
    stuffy nose
    o
    sore throat
    o
    sinus congestion and pressure
  • Warnings

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

    more than 4000 mg 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 persists for more than 2 days, is accompanied or 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

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

    Ask a doctor or pharmacist before use if you are taking

    the blood thinning drug warfarin
  • WHEN USING

    When using this product do not exceed recommended dosage

  • STOP USE

    Stop use and ask a doctor if

    you get nervous, dizzy, or sleepless
    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
    new symptoms appear

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, potassium sorbate, povidone, sodium lauryl sulfate, stearic acid, talc.

    .

  • QUESTIONS

    Questions or comments? call toll-free 1-855-874-0970 (English/Spanish) weekdays

  • PRINCIPAL DISPLAY PANEL

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

    DAY
    CONTAC®
    COLD+FLU

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

    Maximum Strength
    Multi-Symptom

    Nasal Congestion • Sinus Pressure •Sore Throat
    Head & Body Aches • Fever

    24 CAPLETS

    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

    © 2019 Mylan, Inc.

    www.contact.com   UC402424-06-03

    Contac Cold and Flu Day Carton
  • INGREDIENTS AND APPEARANCE
    CONTAC COLD AND FLU  DAY
    acetaminophen and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code MS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46017-024-081 in 1 CARTON07/01/2011
    1NDC:46017-024-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:46017-024-243 in 1 CARTON07/01/2011
    2NDC:46017-024-998 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2011
    Labeler - Mylan Consumer Healthcare, Inc. (831410522)