Label: TARGET MAXIMUM STRENGTH COLD FLU AND SORE THROAT OVERNIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl and triprolidine hcl 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 1, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)
    MAXIMUM STRENGTH COLD, FLU & SORE THROAT
    Purposes

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Pain reliever/fever reducer

    Cough suppressant

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

    Expectorant

    Nasal decongestant

    Active ingredients (in each 20 mL)Purposes
    MAXIMUM STRENGTH OVERNIGHT COLD & FLU

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Triprolidine HCl 2.5 mg

    Cough suppressant

    Antihistamine

  • Uses

    MAXIMUM STRENGTH COLD, FLU & SORE THROAT

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

    Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take:

    more than6 doses in 24 hours which is the maximum daily amount
    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 warnings: 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 pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

  • Overdose warnings.

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you don’t notice any signs or symptoms.

  • Directions

    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 dosing cup with other products
    dose as follows or as directed by a doctor
    mL = milliliter
    adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
    children under 12 years of age: Do not use
  • Other information

    each 20 mL contains: sodium 8 mg
    store at room temperature
    do not refrigerate
  • Inactive ingredients (Maximum strength Cold, Flu and Sore Throat)

    anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red No. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Uses (OVERNIGHT COLD & FLU

    temporarily relieves these common cold and flu symptoms:
    cough
    minor aches and pains
    sore throat
    headache
    runny nose
    sneezing
    itching of the nose or throat
    itchy, watery eyes due to hay fever
    temporarily reduces fever
    controls cough to help you get to sleep
  • Warnings

    Liver warnings: This product contains acetaminophen. Severe liver damage may occur if you take:

    more than 4000 mg in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks daily while using this product

    If pregnant or breast feeding

    ask a health professional before use

    Keep out of reach of children

    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 Centre right away at 1-800-222-1222.

    Quick medical attention is critical for adults as well as for children, even if you do not notice any signs

    Directions

    do not take more than directed (see overdose warnings
    do not take more than 4 doses in any 24-hour period
    measure only with dosing cup provided
    do not use dosing cup with other products
    dose as follows or as directed by a doctor
    adults and children 12 years of age and over: 20 ml in dosing cup provided every 4 hours
    children under 12 years of age: do not use

    Other Information

    each 20 mL contains: sodium 10 mg
    low sodium
    store at room temperature
    do not refrigerate
  • Inactive ingredients (Overnight Cold & Flu)

    anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose and xanthan gum

  • Questions or comments?

    (1-866-467-2748)

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    VALUE PACK

    NDC 11673-691-12

    Compare to active ingredients Maximum Strength Mucinex® Fast Max® Cold, Flu and Sore Throat

    Maximum Strength

    Cold, Flu and Sore Throat

    Acetaminophen • Pain Reliever/Fever Reducer

    Dextromethorphan HBr • Cough Suppressant
    Guaifenesin • Expectorant

    Phenylephrine HCl • Nasal Decongestant

    Controls Cough, Thins & Loosens Mucus
    Nasal & Chest Congestion
    Sinus pressure & Congestion
    Body Pain, Headache, Fever & Sore Throat

    *Per 4-hour dose

    For Ages 12+

    6 FL. OZ. (180 mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.

    Compare to Mucinex® Nightshift Cold, Flu & Sore Throat Active Ingredients**

    Overnight Cold & Flu

    Acetaminophen • Pain Reliever/Fever Reducer
    Dextromethorphan HBr • Cough Suppressant

    Triprolidine HCl • Antihistamine

    Night Time Relief for a Better Morning

    Maximum Strength per 4-hour dose

    Cough
    Fever
    Sore Throat
    Runny Nose
    Sneezing

    For Ages 12+

    6 FL OZ (180 mL)

    **This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu.

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

    See bottle for full labeling

    Distributed by:

    094 14 8715 R00

    C-001227-01-055

    Dist. By Target Corp.

    Mpls., MN 55403

    TM & © 2020

    Target Brands, Inc.

    Questions?

    Cal 1-866-467-2748

    DO NOT TAKE MAXIMUM STRENGTH COLD, FLU & SORE THROAT & OVERNIGHT COLD & FLU LIQUIDS AT THE SAME TIME.

    Target Max Strength Value Pack Cold and Flu Relief
  • INGREDIENTS AND APPEARANCE
    TARGET MAXIMUM STRENGTH COLD FLU AND SORE THROAT  OVERNIGHT COLD AND FLU
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl and triprolidine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-691
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-691-121 in 1 CARTON; Type 0: Not a Combination Product03/30/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    MAXIMUM STRENGTH COLD FLU AND SORE THROAT 
    acetaminophen, dextromethorphan hbr, guaifenesin and phenylephrine hcl solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propyl gallate (UNII: 8D4SNN7V92)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Part 2 of 2
    TARGET OVERNIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hbr, phenylephrine hcl and triprolidine hcl solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    propyl gallate (UNII: 8D4SNN7V92)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/30/2020
    Labeler - TARGET CORPORATION (006961700)