Label: NON-DROWSY DAYTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

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

Drug Label Information

Updated December 8, 2023

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  • Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan hydrobromide 10 mg

    Phenylephrine hydrochloride 5 mg

  • Purposes

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
    • temporarily reduces fever

  • Warnings

    Liver warning:

    This product contains acetaminophen.
    Severe liver damage may occur if you take
    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:

    Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
    • skin reddening
    • blisters
    • rash n hives
    • facial swelling
    • asthma (wheezing)
    • shock
    If a skin or general allergic 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 followed by fever, headache, rash, nausea, or vomiting, consult 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • in children under 12 years of age

    Ask a doctor before use if you have

    • liver disease n heart disease n high blood pressure
    • thyroid disease n diabetes
    • cough with excessive phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    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, cough, 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 occur
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs
    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. 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 the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use

  • Other information

    • store at room temperature. Avoid temperatures above 25°C (77°F).

  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

  • Questions or comments?

    1-888-423-0139

  • Carton

    TopCare health

    NDC 36800-720-24

    COMPARE TO ALKA-SELTZER® PLUS®
    MAXIMUM STRENGTH DAYTIME COLD & FLU
    POWERMAXTM GELS ACTIVE INGREDIENTS*


    NON-DROWSY DAYTIME

    Cold & Flu Max Softgels
    MAXIMUM STRENGTH

    PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
    COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
    NASAL DECONGESTANT - PHENYLEPHRINE HCl

    RELIEVES:
    • Nasal Congestion
    • Cough
    • Headache & Body Ache
    • Sore Throat
    • Sinus Pressure

    •Smaller Capsule •Same Strength

    24SOFTGELS**
    **Liquid-Filled Capsules

    minis

    Carton

  • INGREDIENTS AND APPEARANCE
    NON-DROWSY DAYTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-720
    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) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVAL ((oblong)) Size16mm
    FlavorImprint Code 105
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-720-241 in 1 CARTON04/20/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/20/2022
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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