Ninjacof Solution
FDA Label NDC 23359-032

12 label sections · Submitted to the FDA by Centurion Labs, Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Centurion Labs, Llc for the product Ninjacof (NDC 23359-032). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient section, purpose, indications & usage section, warnings section, otc - when using section, otc - do not use section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Ninjacof 16 Label)

Image Description (Ninjacof 16 Label)

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 (Ninjacof 10ml Label)

Image Description (Ninjacof 10ml Label)

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 (Ninjacof 4oz Label)

Image Description (Ninjacof 4oz Label)

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:

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