Label: CONTAC COLD FLU DAY- phenylephrine hydrochloride, acetaminophen tablet

  • NDC Code(s): 71179-024-08, 71179-024-24
  • Packager: Vespyr Brands, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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

  • Drug Facts

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    Pain reliever/fever reducer
    Nasal decongestant

  • Uses

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

    • 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 or comments?

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

  • SPL UNCLASSIFIED SECTION

    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.

    CONTAC ®

    COLD + FLU DAY

    Non-Drowsy Relief

    DISTRIBUTED BY: Vespyr Brands®, Inc., East Windsor NJ 08520 | Made in Canada | www.contac.com
    CONTAC® is a registered trademark of Vespyr Brands®, Inc. © 2022 Vespyr Brands®, Inc. | UC402408-06-05

  • PRINCIPAL DISPLAY PANEL

    CONTACT®
    COLD + FLU DAY
    Phenylephrine HCl, Acetaminophen
    Nasal Decongestant/Pain Reliever-Fever ReducerMaximum Strength

    Multi-Symptom

    Nasal Congestion

    Sinus Pressure • Sore Throad

    Head & Body Aches • Fever

    8 CAPLETS

    NDC 71179-024-08

    Maximum Strength

    Multi-Symptom

    Nasal Congestion

    Sinus Pressure • Sore Throad

    Head & Body Aches • Fever

    label

  • INGREDIENTS AND APPEARANCE
    CONTAC  COLD FLU DAY
    phenylephrine hydrochloride, acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code sun
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-024-081 in 1 BOX11/30/2022
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:71179-024-243 in 1 BOX11/30/2022
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/30/2022
    Labeler - Vespyr Brands, Inc. (118094893)