Label: COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hbr, triprolidine hcl solution

  • NDC Code(s): 51316-963-45
  • Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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  • Active ingredients (in each 20 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Triprolidine HCl 2.5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Antihistamine

  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • headache
      • minor aches and pains
      • sneezing
      • runny nose
      • itching of the nose or throat
      • cough
      • sore 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

    • 3 or more alcoholic drinks every day while using this product
    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • rash
    • blisters
    • skin reddening

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    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 exceed recommended dosage
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • marked drowsiness may occur
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
    • do not take more than 4 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS
    Health®

    Compare to the active
    ingredients in Mucinex®
    Nightshift® Cold & Flu*

    Nighttime
    Cold & Flu
    ACETAMINOPHEN     - Pain reliever/Fever reducer
    DEXTROMETHORPHAN HBr - Cough suppressant
    TRIPROLIDINE HCl - Antihistamine

    MULTI-SYMPTOM

    Controls cough
    Relieves fever & sore throat
    Relieves runny nose & sneezing

    FOR AGES 12+

    6 FL OZ (177 mL)

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
    SEAL UNDER CAP IS BROKEN OR MISSING

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    *This product is not manufactured or
    distributed by RB Health (US) LLC, owner
    of the registered trademark Mucinex®
    Nightshift® Cold & Flu.

    B-063-45 REV0423A
    50844    REV0423A06345

    Distributed by: CVS Pharmacy, Inc., One CVS Drive
    Woonsocket, RI 02895 © 2023 CVS/pharmacy V-19849

    CVS 44-063

    CVS 44-063

  • INGREDIENTS AND APPEARANCE
    COLD AND FLU  NIGHTTIME
    acetaminophen, dextromethorphan hbr, triprolidine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-963
    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
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-963-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/23/2023
    Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(51316-963) , pack(51316-963)
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