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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 18, 2022

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

    TARGET Maximum Strength Nighttime cold and flu Maximum Strength Daytime Severe Cold

  • INGREDIENTS AND APPEARANCE
    DAYTIME MUCUS RELIEF SEVERE COLD AND NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
    daytime acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci, nighttime acetaminophen, diphenhydramine hci, phenylephrine hci kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-463
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-463-121 in 1 KIT; Type 0: Not a Combination Product01/11/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 177 mL
    Part 21 BOTTLE, PLASTIC 177 mL
    Part 1 of 2
    DAYTIME MUCUS RELIEF SEVERE COLD  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci liquid
    Product Information
    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 finalpart341
    Part 2 of 2
    NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
    acetaminophen, diphenhydraminehci, phenylephrine hci liquid
    Product Information
    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 finalpart34101/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/11/2018
    Labeler - TARGET Corporation (006961700)