Ninjacof D

Ninjacof D
SPL v31
SPL
SPL Set ID 5188aa20-41f1-4998-81e1-f4de055874bc
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlophedianol (12.5 mg) Pyrilamine (30 mg) Pseudoephedrine
Inactive Ingredients
Citric Acid Acetate Glycerin Propylene Glycol Sodium Benzoate Sodium Citrate Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-16

Description

​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


Medication Information

Purpose

Antitussive

Antihistamine

Nasal Decongestant

Description

​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

​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
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.

​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.

​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

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

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.

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

Structured Label Content

Purpose

Antitussive

Antihistamine

Nasal Decongestant

​uses: (​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
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.

​warnings (​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.

​drug Facts (​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

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 (PRINCIPAL DISPLAY PANEL)

When Using This Product (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 (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 (If Pregnant or breast feeding)

Ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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 (Ask doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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