Label: COUGH AND COLD NIGHTTIME- acetaminophen diphenhydramine hci phenylephrine hci liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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

  • Active ingredient (in each 20 mL)

    Acetaminophen 650 mg

    Diphenhydramine HCI 25 mg

    Phenylephrine HCI 10 mg

  • Purpose

    Pain reliever/fever reducer

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms
      • cough
      • nasal congestion
      • minor aches and pains
      • sore throat
      • headache
      • runny nose
      • sneezing
    • 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 4,000 my of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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.
    • with any other drug containing diphenhydramine even one used on the skin
    • 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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
    • avoid alcoholic drinks
    • alcoholic, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating a machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse, or lasts more than 7 days
    • new symptoms occur
    • fever gets worse, or lasts more than 3 days
    • redness or swelling is present
    • cough comes back or occurs with rash or headache that lasts. These could be sign 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 (1-800-222-1222) 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 6 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • mL = milliliter
    • keep dosing cup with product
    • dose as follows or as directed by a doctor
    • adults and children 12 years and older: 20 mL every 4 hours while symptoms last
    • children under 12 years of age: do not use

  • Other information

    • each 20 mL contains: sodium 12 mg 
    • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid,  edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, sorbitol, xanthan gum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Maximum Strength Delsym® Adult Night Time Cough & Cold active ingredients††

    NIGHTTIME

    Cough & Cold

    ACETAMINOPHEN 650 mg / PAIN RELIEVER, FEVER REDUCER

    DIPHENHYDRAMINE HCI 25 mg / ANTIHISTAMINE, COUGH SUPPRESSANT

    PHENYLEPHRINE HCI 10 mg / NASAL DECONGESTANT

    MAXIMUM STRENGTH

    • Relieves headaches, fever & sore throat
    • Controls cough
    • Relieves nasal congestion
    • ages 12 years & older

    FL OZ (mL)

    MIXED BERRY FLAVOR

    ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Delsym® Adult Night Time Cough & Cold

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

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com ©2018 Walgreen Co.

  • Package Label

    Acetaminophen 650 mg, Diphenhydramine HCI 25 mg, Phenylephrine HCI 10 mg

    WALGREENS NightTime Cough & Cold

  • INGREDIENTS AND APPEARANCE
    COUGH AND COLD  NIGHTTIME
    acetaminophen diphenhydramine hci phenylephrine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0747
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 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)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SORBITOL (UNII: 506T60A25R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (MIXED) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0747-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/31/2018
    Labeler - Walgreens (008965063)