Label: NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder

  • NDC Code(s): 73147-3109-6
  • Packager: Cellchem Pharmaceuticals Inc
  • 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 January 11, 2021

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

  • Drug Facts

    Active Ingredients (in each packet)                                                   Purpose

    Acetaminophen 650 mg..................................................Pain reliever/Fever reducer

    Diphenhydramine Hydrochloride 25 mg.............Antihistamine/ Cough Suppressant

    Phenylephrine Hydrochloride 10 mg.............................................Nasal decongestant

  • Uses

    • Temporarily relieves these symptoms due to a cold:
      • minor aches and pains  
      • headache
      • minor sore throat pain
      • nasal and sinus congestion
      • cough due to minor throat and bronchial irritation
      • runny nose
      • sneezing
      • itchy, watery eyes due to hay fever
      • itchy nose or throat
    • Temporarily reduce fever
  • INDICATIONS & USAGE

    Relieves:

    • Nasal congestion
    • Sore throat pain
    • Cough
    • Headache
    • body aches
    • Fever
    • Runny nose
    • Sneezing
  • 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 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

    • in children under 12 years
    • if you are allergic to acetaminophen, phenylephrine or any other ingredient in this product
    • with any other drug containing acetaminophen, phenylephrine. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product 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 a 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 such as emphysema, asthma, or chronic bronchitis 
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a sodium restricted diet.

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
    • the blood thinning drug warfarin 

    When using this product

    • do not exceed recommended dosage
    • avoid alcoholic drinks
    • marked drowsiness may occur 
    • alcohol, sedatives and tranquilizers may increase drowsiness 
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • pain, cough or nasal congestion gets worse or lasts more than 7 days
    • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    If pregnant or breast-feeding, ask a health care professional before use.

    READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
    KEEP CARTON FOR REFERENCE.
    DO NOT DISCARD.
    DO NOT USE IF SEALED PACKET IS TORN OR BROKEN

  • Directions

    • do not use more than directed
    • take every 4 hours, while symptoms persist.

    Do not take more than 6 packets in 24 hours unless directed by a doctor.

    Age

    Dose

    adults and children 12 years and over

    one packet

    children under 12 years

    do not use

    • dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
    • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
  • INFORMATION FOR PATIENTS

    Other Information

    • each packet contains: potassium 10 mg, sodium 47 mg.
    • phenylketonurics: contains phenylalanine 13 mg per packet.
    • store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.
  • Inactive ingredients

    Acesulfame potassium, anhydrous citric acid, aspartame, caramel, D&C Yellow #10, maltodextrin, natural flavors, sodium citrate, starch and sugar.

  • Questions, Comments or Adverse Reactions?

    You may report serious side effects to: +1 844-481-8884
    Serious side effects can also be reported to: drugsafety@cellchempharma.ca

    Distributed by:
    CellChem Pharmaceuticals Inc.
    Unit 1, 30 Concourse Gate
    Nepean, Ontario K2E 7V7

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    cartonlabel

    pouch

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SEVERE COLD COUGH AND FLU RELIEF 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73147-3109
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CARAMEL (UNII: T9D99G2B1R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorHONEY (honey lemon infused with Chamomile & white tea flavors) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73147-3109-66 in 1 CARTON; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2019
    Labeler - Cellchem Pharmaceuticals Inc (111518618)
    Registrant - Cellchem Pharmaceuticals Inc (111518618)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Confab Inc241754217manufacture(73147-3109)