Label: DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for 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 December 4, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each packet)Purposes
    Acetaminophen 650 mgPain reliever/fever reducer
    Diphenhydramine HCl 25 mgAntihistamine/cough suppressant
    Phenylephrine HCl 10 mgNasal decongestant
  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • cough
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • 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 6 packets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    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
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • breathing problems such as emphysema or chronic bronchitis
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin
    • you are 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
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating 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
    • 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 6 packets in any 24-hour period
    • adults and children 12 years of age and older: 1 packet every 4 hours
    • Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes.
    • children under 12 years of age: do not use
  • Other information

    • each packet contains: sodium 130 mg
    • phenylketonurics: contains phenylalanine 41 mg per packet
    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, aspartame, D&C Yellow #10, FD&C Red #40, flavors, saccharin sodium, sodium citrate, sucrose

  • Questions?

    1-888-963-3382

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser
    Parsippany, NJ 07054-0224
    Made in England

  • PRINCIPAL DISPLAY PANEL - 8 Packet Carton

    NDC 63824-110-08

    NEW!

    MAX Strength*

    Delsym®

    COUGH +™ COLD

    NIGHT TIME

    Acetaminophen (Pain Reliever/Fever Reducer)
    Diphenhydramine HCl (Antihistamine/Cough Suppressant)
    Phenylephrine HCl (Nasal Decongestant)

    Cough
    Nasal Congestion
    Sore Throat
    Body Aches
    Fever

    HONEY LEMON
    Flavored Mix

    For Ages 12+

    8 Packets

    PRINCIPAL DISPLAY PANEL - 8 Packet Carton
  • INGREDIENTS AND APPEARANCE
    DELSYM   COUGH PLUS COLD NIGHT TIME
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen650 mg
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride25 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    aspartame (UNII: Z0H242BBR1)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorHONEY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-110-088 in 1 CARTON; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/01/2014
    Labeler - RB Health (US) LLC (081049410)