Label: DAYTIME NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl kit

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

Drug Label Information

Updated April 28, 2025

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

  • Daytime Severe Cold and Flu - Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    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

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves common cold/flu symptoms:

    -nasal congestion
    -sinus congestion & pressure
    -cough due to minor throat & bronchial irritation
    -minor aches & pains
    -headache
    -fever
    -sore throat
    -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: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 softgels in 24 hours, which is the maximum daily amount for this product
    • 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

    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 DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged 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 DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product, do not use more than directed.

  • STOP USE

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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.

  • PREGNANCY 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • take only as directed
    • do not exceed 8 softgels per 24 hrs
      adults & children 12 yrs & over2 softgels with water every 4 hrs
      children 4 to under 12 yrsask a doctor
      children under 4 yrsdo not use
  • OTHER SAFETY INFORMATION

    Other information

    • do not exceed 25°C
  • INACTIVE INGREDIENT

    Inactive ingredients FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • Nighttime Severe Cold and Flu - Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • cough to help you sleep
    • minor aches & pains
    • headache
    • fever
    • sore throat
    • runny nose & sneezing
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
  • WARNINGS

    Warnings

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

    • more than 8 softgels in 24 hours, which is the maximum daily amount for this product
    • 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

    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 DOCTOR

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin
  • WHEN USING

    When using this product

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

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • 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.

  • PREGNANCY 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 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • take only as directed
    • do not exceed 8 softgels per 24 hrs

    adults & children 12 yrs & over2 softgels with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

  • OTHER SAFETY INFORMATION

    Other information

    • do not exceed 25°C
  • INACTIVE INGREDIENT

    Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    627T_CVS Day-Nighttime Severe Softgels

  • INGREDIENTS AND APPEARANCE
    DAYTIME NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, doxylamine succinate, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-527
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-527-242 in 1 CARTON02/01/2025
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 16   in 2 
    Part 22 BLISTER PACK 8   in 2 
    Part 1 of 2
    DAYTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule
    Product Information
    Item Code (Source)NDC:51316-525
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColororangeScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code 73
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 DrugM01202/01/2025
    Part 2 of 2
    NIGHTTIME SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule
    Product Information
    Item Code (Source)NDC:51316-526
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeBULLETSize16mm
    FlavorImprint Code 72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/01/2025
    Labeler - CVS HEALTH CORP (062312574)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(51316-527)