Ninjacof

Ninjacof

Drug Labeling and Warnings

Drug Details

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NINJACOF- chlophedianol hcl and pyrilamine maleate solution 
Centurion Labs, LLC

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.

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Ninjacof

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:

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)

Revised: 2/2019
 
Centurion Labs, LLC


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