Label: COLD AND FLU DAYTIME SEVERE, 24/7 LIFE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet tablet, film coated

  • NDC Code(s): 66715-6515-8
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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

  • Drug Facts

    Drug Facts

  • Active ingredients

    Active ingredients (in each caplet)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    ​Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    Uses

    • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • sinus congestion and pressure
    • sore throat
    • fever
    • headache
    • nasal congestion
    • cough due to minor throat and bronchial irritation
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    ​Warnings

    Liver warning

    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

    Allergy alert: Acetaminophen may cause severe skin reactions.
    Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    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

    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

    Ask a doctor before use

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use

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

    When using this product

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • 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. These could be signs of a serious condition.

    If pregnant 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    • do not take more than directed
    • do not take more than 8 caplets in 24 hours
    • adults and children 12 years and over: take 2 caplets with water every 4 hours
    • children under 12 years: ask a doctor
  • Other information

    Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    Inactive ingredients

    corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate,
    maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch
    glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Questions or comments?1-800-351-2000 (8:30 AM – 5:00 PM CST)

  • Cold & Flu Daytime Severe, 16ct - PDP/Package Label

    [24/7 Life logo]

    Non-Drowsy

    [caduceus]

    Cold & Flu

    DayTime Severe
    Acetaminophen / Pain Reliever/Fever Reducer
    Dextromethorphan HBr / Cough Suppressant
    Guaifenesin / Expectorant
    Phenylephrine HCl / Nasal Decongestant
    Relieves: Headache, Fever, Sore Throat,
    Minor Aches & Pains, Chest Congestion,
    Nasal Congestion, Sinus Pressure, Cough

    compare to Vicks ® DayQuil™
    SEVERE Cold & Flu active ingredients*

    16

    CAPLETS

    Actual Size [caplet image]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU DAYTIME SEVERE, 24/7 LIFE 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;640
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6515-82 in 1 CARTON04/19/2022
    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 DrugM01204/19/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)