Label: CHILDRENS DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution

  • NDC Code(s): 63824-212-64, 63824-212-66
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 10 mL)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
    Phenylephrine HCl 5 mgNasal 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 your child get to sleep
  • 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.
    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on the skin
    • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    • liver disease
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • glaucoma
    • 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 the child is

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed (see Overdose warning)
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • pain, nasal congestion, or cough gets worse or lasts more than 5 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.

    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 even if you do not notice any signs or symptoms.

  • Directions

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

    • each 10 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum


    1
    may contain this ingredient
  • Questions?

    1-866-682-4639
    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US), Parsippany, NJ 07054-0224
    Made in England

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 63824-212-64

    Ages 6 Years+

    Children's

    Delsym ®

    COUGH + Cold

    Night Time

    Acetaminophen(Pain Reliever/Fever Reducer)

    Diphenhydramine HCl (Antihistamine/Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    • Relieves Cough
    • Relieves

      Stuffy Nose
    • Relieves

      Sore Throat
    • Reduces Fever

    BerryFlavor

    4 fl oz (118 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DELSYM  COUGH PLUS COLD NIGHT TIME
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-212
    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 DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-212-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)03/18/201308/31/2019
    2NDC:63824-212-641 in 1 CARTON06/09/2017
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/18/2013
    Labeler - RB Health (US) LLC (081049410)