Label: MAXIMUM STRENGTH DAYTIME SEVERE AND NIGHTTIME COLD AND FLU- daytime- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nightime - acetaminophen, diphenhydramine hci, phenylephrine hci kit

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

Drug Label Information

Updated October 30, 2023

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

  • Active ingredients for Nighttime (in each 20 mL)

    Acetaminophen 650 mg

    Diphenhydramine HCI 25 mg

    Phenylephrine HCI 10 mg 

  • Active ingredients for Daytime (in each 20 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifeenesin 400 mg

    Phenylephrine HCl 10 mg

  • Purpose for Nighttime

    Pain reliever/fever reducer

    Antihistamine/cough suppressant

    Nasal decongestant

  • Purpose for Daytime

    Pain reliever / fever reducer 

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Uses

    Nighttime

    • temporarily relieves these common cold and flu symptoms
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
    • temporarily reduces fever
    • controls cough to help you get to sleep

    Daytime

    • temporarily relieves these common cold and flu symptoms
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • Warnings

    NIGHTTIME and DAYTIME

     Liver warning: This product contain 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 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    Nighttime

    • with any drug containing acetaminophen (prescription or nonprescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other drug containing diphenhydramine, even one used on the skin
    • 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
    • for children under 12 years of age

    Daytime

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for children under 12 years of age
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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

    Nighttime

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Daytime

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are

    Nighttime

    • you are taking the blood thinning drug warfarin
    • you are taking sedative or tranquilizers

    Daytime

    • taking the blood thinning drug warfarin

    When using these products

    Nighttime

    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicile or operating machinery

    Daytime

    • do not use more than directed

    Stop use and ask a doctor if

    Nighttime

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
    • fever gets worse, or last 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 a signs of a serious condition

      Daytime

    • 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,

    Nighttime and DayTime

    ask a health professional before use.

    Keep out of reach of children.

    Nighttime and DayTime

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Nighttime

    • do not take more than directed (see overdose warning)
    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • keep dosing cup with product
    • mL = mililiter
    • dose as follows or as directed by a doctor
    • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
    • children under 12 years of age: do not use

    Daytime

    • do not take more than directed (see Overdose warning)
    • do not take more than 6 doses in any 24-hours period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • dose as follows or as directed by a doctor 
    • keep dosing cup with product 
    • mL = milliliter
    • adults and children 12 years of age and older: 20 mL every 4 hours
    • children under 12 years of age: do not use

  • Other information

    Nighttime

    • each 20 mL contains: sodium 12 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.

    Daytime

    • each 20 mL contains: 12 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    Nighttime

    citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

    Daytime

    citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

  • Principal Display Panel

    NIGHTTIME

    Compare to active ingredients in Maximum Strength Mucinex®Fast-Max® Night Time Cold & Flu**

    maximum strength

    nighttime

    Cold & Flu

    acetaminophen (pain reliever / fever reducer)

    diphenhydramine HCI (antihistamine / cough suppressant)

    phenylephrine HCI (nasal decongestant)

    Relieves aches, fever, sore throat

    controls cough

    relieves nasal congestion

    relieves runny nose and sneezing  

    AGES 12 + YEARS

    DAYTIME

    Compare to active ingredients in Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold*

    maximum strength

    daytime

    Severe Cold

    acetaminophen (pain reliever / fever reducer)

    dextromethorphan HBr (cough suppressant)

    guaifenesin (expectorant)

    phenylephrine HCI (nasal decongestant)

    Relieves aches, fever & sore throat

    Controls Cough

    relieves nasal and chest congestion 

    thins and loosens mucus 

    AGES 12 + YEARS

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    *This prodect is not manufactured or distributed by Recitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Day Time Severe Cold.

    **This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® FAST-MAX® Night Time Cold & Flu.

    Dist. by Target Corp.

    Minneapolis, MN 55403

    Product of U.S.A.

    ©2016 Target Brands, Inc.

    Questions? Call 1-800-910-6874

  • Product Label

    Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg Acetaminophen 650 mg, Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DAYTIME SEVERE AND NIGHTTIME COLD AND FLU 
    daytime- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nightime - acetaminophen, diphenhydramine hci, phenylephrine hci kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-339
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-339-011 in 1 KIT; Type 0: Not a Combination Product05/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 177 mL
    Part 21 BOTTLE, PLASTIC 177 mL
    Part 1 of 2
    MAXIMUM STRENGTH DAYTIME SEVERE COLD 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
    Product Information
    Item Code (Source)NDC:11673-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2024
    Part 2 of 2
    MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
    acetaminophen, diphenhydramine hci, phenylephrine hci liquid
    Product Information
    Item Code (Source)NDC:11673-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2024
    Labeler - TARGET Corporation (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED677604129manufacture(11673-339)