Label: CONTAC COLD FLU DAY NIGHT- acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • Drug Facts (Day)

  • Active ingredients(in each caplet) (Day)

    Acetaminophen 500 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes (Day)

    Pain reliever/fever reducer
    Nasal decongestant

  • Uses (Day)

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

  • Warnings (Day)

    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 • trouble urinating due to disease an enlarged prostate gland

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

    When using this product do not exceed recommended dosage.

    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 (Day)

    • do not take more than directed (see overdose warning).
    • adults and children 12 yrs of age and over: take 2 caplets every 6 hrs as needed.
    • do not take more than 8 caplets in 24 hrs.
    • children under 12 yrs of age: ask a doctor.

  • Other information (Day)

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients (Day)

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

  • Questions or comments? (Day)

    call toll-free 1-855-874-0970 (English/Spanish) weekdays

  • Drug Facts (Night)

  • Active ingredients (in each caplet) (Night)

    Acetaminophen 500 mg
    Chlorpheniramine maleate 2 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes (Night)

    Pain reliever/fever reducer
    Antihistamine
    Nasal decongestant

  • Uses (Night)

    Temporarily relieves common cold/flu symptoms:
    • nasal congestion • sneezing • headache
    • runny nose • fever • sore throat
    • minor aches and pains

  • Warnings (Night)

    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.

    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 (Night)

    • 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 (Night)

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients (Night)

    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? (Night)

    call toll-free 1-855-874-0970 (English/Spanish) M - F, 8am -5pm EST

  • SPL UNCLASSIFIED SECTION

    NDC 71179-025-28

    CONTAC ®

    COLD + FLU

    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

    Maximum Strength

    Multi-Symptom

    DISTRIBUTED BY:

    Vespyr Brands ®, Inc.

    East Windsor NJ 08520

    ©2022 Vespyr Brands ®, Inc.

    All rights reserved

    CONTAC ® is a registered trademark of Vespyr Brands ®, Inc.

    www.contac.com

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CONTAC  COLD FLU DAY NIGHT
    acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-025
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-025-281 in 1 BOX; Type 0: Not a Combination Product12/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BLISTER PACK 2 
    Part 20 BLISTER PACK 1 
    Part 1 of 2
    CONTAC  COLD FLU DAY
    phenylephrine hydrochloride, acetaminophen tablet
    Product Information
    Item Code (Source)NDC:71179-024
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code sun
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Part 2 of 2
    CONTAC  COLD FLU NIGHT
    acetaminophen, chlorpheniramine maleat, phenylephrine hydrochloride tablet
    Product Information
    Item Code (Source)NDC:71179-026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code moon
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2023
    Labeler - Vespyr Brands, Inc. (118094893)
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