Label: MAXIMUM STRENGTH DAYTIME COLD AND FLU AND NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride,triprolidine hydrochloride kit

  • NDC Code(s): 11673-286-01, 11673-295-03, 11673-872-03
  • Packager: TARGET CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 22, 2024

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

  • Drug Facts

    Daytime Cold & Flu

  • ACTIVE INGREDIENT

    Daytime Cold & Flu

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

    Nighttime Severe Cold and Flu

    Active ingredients (in each 20 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

    Triprolidine HCl 2.5 mg

    Purposes

    Daytime Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

    Nighttime Severe Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Antihistamine

  • Uses

    Daytime Cold & Flu

    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
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

    Nighttime Severe Cold & Flu

    temporarily relieves these common cold and flu symptoms:

    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • sinus congestion and pressure
    • 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 warning

    Daytime Cold & Flu

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

    • more than 6 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

    Nighttime Severe Cold & Flu

    Liver warning: 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

    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

    • 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.

    Ask a doctor before use if you have

    Daytime Cold & Flu

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

    Nighttime Severe Cold & Flu

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • 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, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor or pharmacist before use if you are

    Daytime Cold & Flu

    • taking the blood thinning drug warfarin

    Nighttime Severe Cold and Flu

    • ​taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children (Nightshift Severe Cold & Flu only)
    • marked drowsiness may occur (Nightshift Severe Cold & Flu only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Severe Cold & Flu only)
    • avoid alcoholic drinks (Nightshift Severe Cold & Flu only)
    • use caution when driving a motor vehicle or operating machinery (Nightshift Severe Cold & Flu only)

    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 fever, rash, or headache that lasts.

    These could be signs of a serious condition.

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Daytime Cold & Flu

    • 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
    • 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

    Nighttime Severe Cold and Flu

    • do not take more than directed (see Overdose warning)
    • 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

    Daytime Cold & Flu

    • each 20 mL contains: sodium 12 mg
    • store at 20-25°C (68-77°F)
    • do not refrigerate

    Nighttime Severe Cold and Flu

    • each 20 mL contains: sodium 17 mg
    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    Daytime Cold & Flu

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

    Nighttime Severe Cold and Flu

    anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    daynight-sleeve-labeldaytime-part-labelnighttime-part-label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DAYTIME COLD AND FLU AND NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride,triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-286
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-286-011 in 1 CARTON05/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 21 BOTTLE 180 mL
    Part 1 of 2
    NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC:11673-872
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-872-03180 mL in 1 BOTTLE; 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
    DAYTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC:11673-295
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-295-03180 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 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(11673-286)