NINJACOF- chlophedianol hcl and pyrilamine maleate solution

Ninjacof by

Drug Labeling and Warnings

Ninjacof by is a Otc medication manufactured, distributed, or labeled by Centurion Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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:

INGREDIENTS AND APPEARANCE

NINJACOF 
chlophedianol hcl and pyrilamine maleate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23359-032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL)	PYRILAMINE MALEATE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23359-032-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2014
2	NDC: 23359-032-10	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2017
3	NDC: 23359-032-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/2014

Labeler - Centurion Labs, LLC (016481957)