Label: NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin kit

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

Drug Label Information

Updated December 7, 2023

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

  • Drug Facts

    Non Drowsy Severe Daytime Cold and Flu Relief

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • 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

    Liver warning This product contains acetaminophen. Severe liver damage may occur if you take
    ■ more than 4 doses 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

    ■ 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

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

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

    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.

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

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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

    ■ take only as directed - see Overdose warning
    ■ do not exceed 4 doses per 24 hours

    adults & children 12 years & over2 softgels with water every 4 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use

    ■ when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

  • Other information

    ■ store at room temperature

  • Inactive ingredients

    FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Drug Facts 

    Severe Nighttime Cold and Flu Relief

  • Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine
    Nasal decongestant

  • 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 thr

  • Warnings

    Liver warning This product contains acetaminophen. Severe liverdamage may occur if you take
    ■ more than 4 doses in 24 hours, which is the maximum dailyamount 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

    ■ 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.
    ■ to make a child sleep

    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 a doctor or pharmacist before use if you are

    ■ taking sedatives or tranquilizers
    ■ taking the blood thinning drug warfarin

    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 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.

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

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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

    ■ take only as directed - see Overdose warning
    ■ do not exceed 4 doses per 24 hours

    adults & children 12 years & over2 softgels with water every 4 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yearsdo not use

  • Other information

    store at room temperature

  • Inactive ingredients

    D&C Yellow #10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide

  • Questions or comments?

    Call toll free: 1-888-333-9792

  • Principal Display Panel

    CVS DT NT Image

  • INGREDIENTS AND APPEARANCE
    NON DROWSY SEVERE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride, guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-106
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-106-241 in 1 CARTON; Type 1: Convenience Kit of Co-Package11/10/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BLISTER PACK
    Part 20 BLISTER PACK
    Part 1 of 2
    NON DROWSY SEVERE DAYTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:51316-104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 341;A13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/10/2022
    Part 2 of 2
    SEVERE NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Item Code (Source)NDC:51316-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    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) PHENYLEPHRINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 116;A07
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/10/2022
    Labeler - CVS Pharmacy (062312574)