NINJACOF-D (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CENTURION LABS, LLC]

NINJACOF-D (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [CENTURION LABS, LLC]
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NDC 23359-034-04, 23359-034-16
Set ID 5188aa20-41f1-4998-81e1-f4de055874bc
Category HUMAN OTC DRUG LABEL
Packager Centurion Labs, LLC
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • ​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)

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