Label: NINJACOF-D- chlophedianol hydrochloride, pyrilamine maleate, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 23359-034-04, 23359-034-16
  • Packager: Centurion Labs, LLC
  • 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 15, 2020

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

  • ​Drug Facts

    ​Active Ingredients (in each 5 mL (1 tsp))           Purpose

    ​Chlophedianol HCl           12.5 mg...........................Cough Suppressant

    Pyrilamine Maleate          12.5 mg...........................Antihistamine

    Pseudoephedrine HCl          30 mg...........................Nasal Decongestant

  • Purpose

    Antitussive

    Antihistamine

    Nasal Decongestant

  • ​Uses:

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies.

    • Cough due to minor throat and bronchial irritation
    • Runny Nose
    • Sneezing
    • Itching of the nose or throat
    • Itchy, watery eyes
    • Nasal Congestion
    • Reduces swelling of nasal passages
  • ​WARNINGS

    ​Do not exceed recommended dosage

    Do not use this product if

    • you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
  • Ask doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers
  • When using this product

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic beverages
    • 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 occurs
    • symptoms do not improve within 7 days or are accompanied by a fever,
    • rash, or persistent headache. A persistent cough may be a sign of a serious condition
    • new symptoms occur
  • If Pregnant or breast feeding

    Ask a health professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Do not exceed recommended dosage.

     Adults and Children
    12 Years or Older.
     5-10ml (1-2 tsp) every 6 to 8 hours
    not to exceed 40ml in 24hr
     Children 6-12 5ml (1 tsp) every 6 to 8 hours not to
    exceed 20ml in 24hr
     Children under 6
    years of age
     Consult a doctor.

  • Other Information

    Store at 59° - 85° F (15° - 30° C)

  • Inactive Ingredients

    Citric Acid, Glycerin, Natural & Artificial Flavors, Propylene Glycol, Sodium Benzoate, Sodium Citrate, Sucralose, Water

  • Questions? Comments?

    To report a serious adverse event or obtain product information, contact 1-866-959-4880

  • PRINCIPAL DISPLAY PANEL

    label 16oz

    23359-034-16

    Ninjacof ​™​-D

    Antitussive, Antihistamine, Nasal Decongestant

    Each teaspoonful (5mL) Contains:

    Chlophedianol HCl........................................12.5 mg

    Pyrilamine Maleate.......................................12.5 mg

    Pseudoephedrine HCl....................................30.0 mg

    Alchohol Free, Dye Free, Sugar Free

    Cotton Candy Flavor

    Centurion

    16 fl oz (473 mL)

    Manufactured for:  Centurion Labs, LLC Birmingham, AL 35243

    Rev 07/2017

  • PRINCIPAL DISPLAY PANEL

    label-4oz

    23359-034-04

    Ninjacof™-D

    Antitussive, Antihistamine, Nasal Decongestant

    Each Teaspoonful (5 mL) Contains:

    Chlohedianol HCl......................................12.5 mg

    Pyrilamine Maleate...................................12.5 mg

    Pseudoephedrine HCl................................30.0 mg

    Alcohol Free, Dye Free, Sugar Free

    Cotton Candy Flavor

    Centurion

    4 fl oz (120 mL)

    Manufactured for: Centurion Labs, LLC Birmingham, AL 35243

    Rev. 10/2018

  • INGREDIENTS AND APPEARANCE
    NINJACOF-D 
    chlophedianol hydrochloride, pyrilamine maleate, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23359-034
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE12.5 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23359-034-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2017
    2NDC:23359-034-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/16/2017
    Labeler - Centurion Labs, LLC (016481957)