Label: NON DROWSY DAYTIME AND NIGHTTIME SINUS CONGESTION AND COUGH RELIEF- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

  • Category: HUMAN OTC DRUG LABEL

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 February 11, 2020

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  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief Active ingredients (in each softgel)

    Acetaminophen 325 mg  

    Dextromethorphan hydrobromide 10 mg
    Phenylephrine hydrochloride 5 mg

  •  NIGHTTIME Sinus Congestion and Cough Relief Active ingredients (in each softgel)

    Acetaminophen 325 mg
    Dextromethorphan hydrobromide 10 mg
    Doxylamine succinate 6.25 mg
    Phenylephrine hydrochloride 5 mg

  • Purposes

    Non Drowsy DAYTIME Sinus Congestion and Cough Relief

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

  • Purposes

    Nighttime Sinus Congestion and Cough Relief

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    Non Drowsy DAYTIME Sinus Congestion and Cough Relief

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • cough
      • sore throat
      • nasal and sinus congestion
    • temporarily reduces fever
  • Uses

    NIghttime Sinus Congestion and Cough Relief

    • temporarily relieves these symptoms due to a cold or flu:
      • minor aches and pains
      • headache
      • nasal and sinus congestion
      • cough
      • sore throat
      • runny nose
      • sneezing
    • temporarily reduces fever
  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief Warnings

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 4000 mg of Acetaminophen 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

    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.

    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.

    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 you have ever had an allergic reaction to this product or any of its ingredients
    • in children under 12 years of age  

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough with excessive phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema   

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

    When using this product do not exceed recommended dosage 

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  

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

    Keep out of reach of children.

    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.

  • Nighttime  Sinus Congestion and Cough Relief Warnings

    Liver warning

    These products contain acetaminophen. Severe liver damage may occur if you take

    • more than 4000 mg of Acetaminophen 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

    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.

    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.

    Do not use to sedate children.

    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 you have ever had an allergic reaction to this product or any of its ingredients
    • in children under 12 years of age  

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma 
    • cough with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema   

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    • do not exceed recommended dosage 
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  

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

    Keep out of reach of children.

    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.

  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • Nighttime Sinus Congestion and Cough Relief Directions

    • do not take more than the recommended dose
    • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
    • children under 12 years: do not use
  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief Other information

    • store at room temperature. Avoid excessive heat.
  • Nighttime Sinus Congestion and Cough Relief Other information

    • store at room temperature. Avoid excessive heat.
  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene
    glycol-400, povidone, propylene glycol, purified water, sorbitol sorbitan,
    titanium dioxide

  • Nighttime Sinus Congestion and Cough Relief Inactive ingredients

    D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene
    glycol-400, povidone, propylene glycol, purified water, shellac, sorbitol
    sorbitan, sodium hydroxide, titanium dioxide

  • Non Drowsy DAYTIME Sinus Congestion and Cough Relief

    Questions or comments?1-888-333-9792

  • Nighttime Sinus Congestion and Cough Relief

    Questions or comments?1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    CVS NON-DROWSY DAYTIME and NIGHTTIME Sinus Congestion and Cough Relief  20ct

    Compare to the active ingredients in

    Alka-Seltzer PLUS® Maximum Strength Severe Congestion & Cough Day & Night Liquid Gels*

     Daytime NON-DROWSY

    Sinus Congestion & Cough Releif

    ACETAMINOPHEN- Pain reliever; Fever reducer

    DEXTROMETHORPHAN HBr - Cough suppressant

    PHENYLEPHRINE HCI - Nasal decongestant

    Relieves:

    Nasal & Sinus congestion; Sinus Pressure;  Headache & body ache; Cough

    12 SOFTGELS

    NIGHTTIME

    Sinus Congestion & Cough Relief

    ACETAMINOPHEN- Pain reliever; Fever reducer

    DEXTROMETHORPHAN HBr - Cough suppressant

    DOXYLAMINE SUCCINATE - Antihistamine

    PHENYLEPHRINE HCI - Nasal decongestant

    Relieves:

    Sinus Congestion & Pressure; Headache & pain; Runny nose & sneezing; Cough

    8 SOFTGELS

    20 TOTAL

    THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND

    TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT

    *This product is not manufactured or distributed by Bayer

    Healthcare LLC, owner of the registered trademark

    Alka-Seltzer PLUS® Maximum Strength Severe Sinus Contestion & Cough Day & Night Liquid Gels.

    image description

  • INGREDIENTS AND APPEARANCE
    NON DROWSY DAYTIME AND NIGHTTIME SINUS CONGESTION AND COUGH RELIEF 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-629
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-629-201 in 1 CARTON; Type 0: Not a Combination Product02/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 BLISTER PACK
    Part 1 of 2
    NON DROWSY DAYTIME SINUS CONGESTION AND COUGH RELIEF 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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
    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 (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (transparent) Scoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code 512
    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 finalpart34102/11/2020
    Part 2 of 2
    NIGHTTIME SINUS CONGESTION AND COUGH RELIEF 
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
    Product Information
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 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 (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorgreen (transparent) Scoreno score
    ShapeCAPSULE (oblong) Size21mm
    FlavorImprint Code 116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    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 finalpart34102/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/11/2020
    Labeler - CVS PHARMACY, INC. (062312574)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(69842-629)