Label: MULTI SYMPTOM NIGHTTIME COLD- acetaminophen diphenhydramine hci phenylephrine hci liquid

  • 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 21, 2022

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

  • Active ingredients (in each 10 mL)

    Acetaminophen 325 mg

    Diphenhydramine HCI 12.5 mg

    Phenylephrine HCI 5 mg

  • Purpose

    Pain reliever / fever reducer

    Antihistamine / Cough suppressant

    Nasal Decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms
    • minor aches and pains 
    • headache
    • sore throat
    • sneezing
    • runny nose  
    • nasal congestion
    • cough
    • controls cough to help your child get to sleep
    • temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

    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 
    • in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product
    • with any other drug containing diphenhydramine, even one used on skin.
    • If your child is allergic to acetaminophen or any of the inactive ingredients in this product
    • to make a child sleepy


    Ask a doctor before use if you have

    • liver disease
    • heart disease 
    • thyroid disease
    • diabetes
    • glaucoma
    • high blood pressure
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (mucus)


    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfain
    • taking sedative or tranquilizers

    When using these products

    • do not use more than directed
    • marked drowsiness may occur
    • excitablity may occur, especially in children
    • sedatives and tranquilizer may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or last more than 5 days
    • redness or swelling is present
    • new symptoms occurs
    • fever gets worse or lasts more than 3 days
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions.


    .

    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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see Overdose warning)
    • do not give more than 5 doses in any 24-hour period
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 days unless directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device.
    • mL = milliliter
    • dose as follows or as directed by a doctor
    • children 6 to under 12 years of age: 10 mL every 4 hours
    • children under 6 years of age: do not use



  • Other information

    • each 10 mL contains: sodium 5 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate.


  • Inactive ingredients

    citric acid, disodium EDTA, FD&C Blue #1, FD&C red #40, Flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum


  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**

    Children's

    multi-symptom

    Nighttime Cold

    ACETAMINOPHEN 325 mg (pain reliever / fever reducer)

    DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)

    PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)

    Relieves:

    Nasal congestion

    Reduces fever

    Soothes cough and sore throat

    Ages 6 to 11 Years

    Berry Flavor Liquid

    Dosage Cup Included

    FL OZ (mL)

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    **This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS.com® 1-800-SHOP CVS

  • Product Label

    Acetaminophen 325 mg, Diphenhydramine HCI 12.5 mg, Phenylephrine HCI 5 mg

    CVS HEALTH Children's Multi-Symptom Nighttime Cold Berry Flavor

  • INGREDIENTS AND APPEARANCE
    MULTI SYMPTOM NIGHTTIME COLD 
    acetaminophen diphenhydramine hci phenylephrine hci liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-506
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    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)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (Mixed) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-506-041 in 1 BOX04/30/201804/30/2025
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/30/201804/30/2025
    Labeler - CVS Pharmacy (062312574)