Ninjacof

Ninjacof
SPL v24
SPL
SPL Set ID e2bca40f-9c27-ec8b-2ff0-ef9847ba2037
Route
ORAL
Published
Effective Date 2017-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-15

Description

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

Purpose

Antitussive Antihistamine

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].


Medication Information

Purpose

Antitussive

Antihistamine

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].

Description

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

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 Questions Section

Questions? Comments?

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

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 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
Inactive Ingredient Section

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

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
Otc Active Ingredient Section

Active ingredients (in each 5 ml) Purpose

Chlophedianol HCI 12.5 mg ..................................... Antitussive

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

Package Label.principal Display Panel

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:

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:

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:

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.


Structured Label Content

Purpose

Antitussive

Antihistamine

Warnings Section (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 Questions Section (OTC - QUESTIONS SECTION)

Questions? Comments?

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

Otc Do Not Use Section (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 When Using Section (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
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 INGREDIENT SECTION)

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

Indications & Usage Section (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
Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Active ingredients (in each 5 ml) Purpose

Chlophedianol HCI 12.5 mg ..................................... Antitussive

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

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:

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:

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:

Otc Pregnancy Or Breast Feeding Section (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 (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.


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