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

  • 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 November 10, 2022

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

  • 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

    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
    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

    pain 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 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 10 mg
    low sodium
    store at room temperature
    do not refrigerate
  • Inactive ingredients

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

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel - 180 mL Bottle Label

    NDC 0363-6980-06

    Overnight Cold & Flu

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

    NIGHT TIME
    Relief for a Better Morning

    Cough
    Fever
    Sore throat
    Runny nose
    Sneezing

    6 FL OZ (180 mL)For Ages 12+

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

    Maximum Strength per 4-hour dose

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

    Walgreen Overnight Cold and Flu Relief
  • INGREDIENTS AND APPEARANCE
    OVERNIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hbr, triprolidine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6980
    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)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6980-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product01/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/28/2020
    Labeler - WALGREENS CO (008965063)