Label: CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH OVERNIGHT COLD AND FLU CLEAR AND COOL- dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen 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 April 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)
    Maximum Strength Severe Congestion & Cough    		Purposes

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Guaifenesin 400 mg

    Phenylephrine HCl 10 mg

    Expectorant

    Nasal decongestant
    Active ingredients (in each 20 mL)Purposes
    Overnight Cold & Flu Clear & Cool

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

    Antihistamine/cough suppressant

    Nasal decongestant

    Triprolidine HCl 2.5 mg

    Antihistamine
  • Uses

    MAXIMUM STRENGTH SEVERE CONGESTION & COUGH

    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    ▪
    temporarily relieves
    ▪
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    ▪
    the intensity of coughing
    ▪
    nasal congestion due to a cold
    ▪
    temporarily helps you cough less
  • Warnings

    Do not use

    •
    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

    ▪
    heart disease
    ▪
    high blood pressure
    ▪
    thyroid disease
    ▪
    diabetes
    ▪
    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)

    When using this product do not use more than directed

    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 Centre right away at 1-800-222-1222

  • Directions

    ▪
    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 older: 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 6 mg
    ▪
    low sodium
    ▪
    store at room temperature
    ▪
    do not refrigerate
    ▪
    dosing cup provided
  • Inactive ingredients (Maximum strength mucus relief DM)

    anhydrous citric acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No.1, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Uses (OVERNIGHT COLD & FLU CLEAR & COOL

    ▪
    temporarily relieves these common cold and flu symptoms:
    ▪
    cough
    ▪
    nasal congestion
    ▪
    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
    ▪
    store at room temperature
    ▪
    do not refrigerate
  • Inactive ingredients (Overnight Cold & Flu)

    anhydrous citric acid, ascorbic acid, D&C Yellow No. 10, edetate disodium, FD&C Blue No. 1, 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 69842-967-12

    Compare to Mucinex® Fast Max® DM Maximum Strength Severe Congestion & Cough Clear & Cool™ Active Ingredients*

    Maximum Strength

    Severe Congestion & Cough

    Dextromethorphan HBr • Cough Suppressant
    Guaifenesin • Expectorant

    Phenylephrine HCl • Nasal Decongestant

    •
    Controls Cough
    •
    Relieves Nasal & Chest Congestion
    •
    Thins & Loosens Mucus

    Cooling Menthol Flavor

    Naturally and Artificially Flavored

    For Ages 12+

    6 FL. OZ. (180 mL)

    *This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength Severe Congestion & Cough Clear & Cool™

    Compare to Mucinex® Nightshift Cold & Flu Clear & Cool Active Ingredients**

    Overnight Cold & Flu

    Clear & Cool

    Acetaminophen • Pain Reliever/Fever Reducer
    Dextromethorphan HBr • Cough Suppressant
    Phenylephrine HCl • Nasal Decongestant

    Triprolidine HCl • Antihistamine

    Maximum Strength per 4-hour dose

    Night Time Relief for a Better Morning

    •
    Cough
    •
    Fever
    •
    Sore Throat
    •
    Runny Nose
    •
    Sneezing
    •
    Nasal Congestion

    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 Clear & Cool.

    DO NOT TAKE MAXIMUM STRENGTH SEVERE CONGESTION & COUGH & OVERNIGHT COLD & FLU CLEAR & COOL LIQUIDS AT THE SAME TIME.

    CVS Value Pack Maximum Strength Severe Congestion & Cough Overnight Cold and Flu Clear and cool
  • INGREDIENTS AND APPEARANCE
    CVS MAXIMUM STRENGTH SEVERE CONGESTION AND COUGH  OVERNIGHT COLD AND FLU CLEAR AND COOL
    dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen and triprolidine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-967
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-967-121 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 SEVERE CONGESTION AND COUGH 
    dextromethorphan hbr, guaifenesin and phenylephrine hcl solution
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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
    ColorGREENScore    
    ShapeSize
    FlavorMENTHOL (COOLING MENTHOL) Imprint 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
    CVS OVERNIGHT COLD AND FLU CLEAR AND COOL 
    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
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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
    ColorGREENScore    
    ShapeSize
    FlavorMENTHOL (COOLING MENTHOL) Imprint 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 - CVS (062312574)
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