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

Drug Label Information

Updated January 31, 2024

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  • 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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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 DrugM01210/15/2014
    Labeler - Centurion Labs, LLC (016481957)
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