Label: DAYTIME COLD AND FLU MAX MAXIMUM STRENGTH SOFTGELS- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Nasal decongestant

  • Uses

    temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • cough due to minor
    • throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever

  • Warnings

    Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
    • more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily 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, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough as occurs with smoking, asthma, or emphysema

  • 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 use more than directed.

  • STOP USE

    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or headache that lasts.

  • 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.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

  • Directions

    take only as directed  do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over2 Softgels with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

  • Other information

    • store between 20-25°C (68-77°F).
    Avoid high humidity and excessive heat.
    Protect from light.

  • Questions or comments?

    1-800-373-6981 (toll-free)

  • Inactive ingredients

    FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water,
    silver sheen, sorbitol solution

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Topco Associates LLC
    Itasca, IL 60143

  • PRINCIPAL DISPLAY PANEL

    TopCare health

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  • INGREDIENTS AND APPEARANCE
    DAYTIME COLD AND FLU MAX MAXIMUM STRENGTH SOFTGELS 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-912
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SD14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-912-242 in 1 CARTON09/25/2024
    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 DrugM01209/25/2024
    Labeler - Topco Associates, LLC (006935977)