Label: CVS OVERNIGHT COLD AND FLU CLEAR AND COOL- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution

  • 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 September 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 20 mg

    Cough suppressant

    Phenylephrine HCl 10 mg

    Nasal decongestant

    Triprolidine HCl 2.5 mg

    Antihistamine
  • Uses

    •
    temporarily relieves these common cold and flu symptoms:
    •
    cough
    •
    nasal congestion
    •
    minor aches and pains
    •
    sore throat
    •
    headache
    •
    runny nose
    •
    sneezing
    •
    sinus congestion and pressure
    •
    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

    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

    ▪
    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

    ▪
    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
    •
    marked drowsiness may occur
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness
    ▪
    avoid alcoholic drinks
    ▪
    use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    ▪
    nervousness, dizziness, or sleeplessness occur
    ▪
    pain, nasal decongestion, 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

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    ▪
    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

    •
    each 20 mL contains: sodium 10 mg
    •
    store at room temperature
    •
    do not refrigerate
  • Inactive ingredients

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

  • Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

    NDC 69842-966-06

    Nighttime Cold & Flu Clear & Cool

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Phenylephrine HCl – Nasal Decongestant
    Triprolidine HCl – Antihistamine

    MULTI-SYMPTOM

    •
    Controls Cough
    •
    Relieves fever & sore throat
    •
    Relieves Runny Nose & Sneezing
    •
    Nasal decongestant

    6 FL OZ (180 mL)
    FOR AGES 12+

    Tamper evident: do not use if printed seal under cap is broken or missing.

    Distributed by:

    CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

    © 2020 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS V-12431

    CVS® Quality

    Money Back Guarantee

    *This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu Clear & Cool.

    CVS Health Nighttime Cold and Flu
  • INGREDIENTS AND APPEARANCE
    CVS OVERNIGHT COLD AND FLU CLEAR AND COOL 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-966
    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
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-966-06180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2020
    Labeler - CVS PHARMACY, INC (062312574)
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