Label: NINJACOF- chlophedianol hcl and pyrilamine maleate solution

  • NDC Code(s): 23359-032-04, 23359-032-10, 23359-032-16
  • 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.

  • OTC - ACTIVE INGREDIENT SECTION

    Active ingredients (in each 5 ml) Purpose
    Chlophedianol HCI 12.5 mg ..................................... Antitussive
    Pyrilamine Maleate 12.5 mg ................................. Antihistamine

  • Purpose

    Antitussive

    Antihistamine

  • INDICATIONS & USAGE SECTION

    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
    • calms the cough control center and relieves coughing
    • runny nose
    • sneezing
    • itching of the nose and throat
    • itchy, watery eyes
  • WARNINGS SECTION

    WARNINGS
    Do not exceed recommended dosage

    DO NOT USE IF PRINTED SAFETY SEAL IS MISSING OR BROKEN

    • If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinsons 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)

    Ask a doctor or pharmacist before us if you are:

    • Taking sedatives or tranquilizers
    • If you have a breathing problem such as emphysema or chronic bronchitis
    • If you have glaucoma
    • If you have difficult in urination due to enlargement of the prostate gland
  • OTC - WHEN USING SECTION

    When using this product

    • Excitability may occur, especially in children
    • Marked drowsiness may occur
    • Avoid alcoholic drinks
    • Alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • Be careful when driving a motor vehicle or operating machinery
  • OTC - DO NOT USE SECTION

    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
  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding

    Ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center immediately.

  • Dosage and Administration

    Directions

    Do not exceed recommended dosage. Use calibrated measuring device for administering the drug to a child.

    Adults and children
    12 years of age
    and over:
    2 teaspoonfuls (10 ml) every 6 to 8
    hours, not to exceed 6 teaspoonfuls in
    24 hours, or as directed by a doctor.
     Children 6 to under
    12 years of age:
    1 teaspoonful (5 ml) every 6 to 8 hours,
    not to exceed 3 teaspoonfuls in 24 hours,
    or as directed by a doctor.
     Children under
    6 years of age:
     Consult a doctor.

    Other Information Store at 20° -25°C (68°-77°F); excursions permitted to 15°-30°C (59° - 86°F). [See USP Controlled Room Temperature].

  • INACTIVE INGREDIENT SECTION

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

  • OTC - QUESTIONS SECTION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

    23359-032-16

    Ninjacof

    Antitussive, Antihistamine

    Each teaspoonful (5mL) Contains:

    Chlophendianol HCl......................12.5mg

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

    Alcohol Free Dye Free, Sugar Free

    Cotton Candy Flavor

    Centurion

    16 fl oz (473 mL)

    Manufactured for Centurion Labs, LLC Birmingham, AL 35243

    Rev: 2/2015

    EXP:

    Lot:

    image description

    23359-032-10

    Ninjacof

    Antitussive, Antihistamine

    Each teaspoonful (5mL) Contains:

    Chlophendianol HCl......................12.5mg

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

    Alcohol Free Dye Free, Sugar Free

    Cotton Candy Flavor

    Centurion

    16 fl oz (473 mL)

    Manufactured for Centurion Labs, LLC Birmingham, AL 35243

    Rev: 2/2015

    EXP:

    Lot:

    image description

    23359-032-04

    Ninjacof

    Antitussive, Antihistamine

    Each teaspoonful (5 mL) Contains:

    Chlophendianol HCl......................12.5mg

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

    Alcohol Free Dye Free, Sugar Free

    Cotton Candy Flavor

    Centurion

    16 fl oz (473 mL)

    Manufactured for Centurion Labs, LLC Birmingham, AL 35243

    Rev: 2/2015

    EXP:

    Lot:

  • INGREDIENTS AND APPEARANCE
    NINJACOF 
    chlophedianol hcl and pyrilamine maleate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23359-032
    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
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23359-032-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/15/2014
    2NDC:23359-032-1010 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2017
    3NDC:23359-032-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2014
    Labeler - Centurion Labs, LLC (016481957)