NINJACOF-A - ninjacof-a liquid 
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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Active Ingredients (in each 5 mL)Purposes
Acetaminophen 160 mg Pain Reliever
Chlophedianol HCl 12.5 mg Antitussive
Pyrilamine Maleate 12.5mgAntihistamine

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Warnings

Liver Warning; This product contains acetaminophen. Severe Liver damage may occur if:

Ask a doctor or pharmacist before you use

A persistent cough may be a sign of a serious condition

When using this product

Stop use and ask a doctor if

These could be signs of serious condition.

DO NOT USE

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 Poison Control Center immediately.

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 (10mL) 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 (5mL) 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 Ingredients

Cotton Candy Flavor, Methylparaben, Polyethlyene Glycol 400, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose

Questions? Comments?

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

PRINCIPAL DISPLAY PANEL

23359-033-16

NinjacofTM-A

Pain Reliever • Fever Reducer • Antitussive • Anithistamine

Each teaspoonful (5mL) Contains:

Acetaminophen...........................160mg
Chlophedianol HCI.....................12.5mg
Pyrilamine Maleate.....................12.5mg

Alcohol Free • Dye Free • Sugar Free

Cotton Candy
Flavor

CENTURION

16 fl oz (473 mL)

Ninjacof-A
NINJACOF-A  
ninjacof-a liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23359-033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
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
Methylparaben (UNII: A2I8C7HI9T)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
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:23359-033-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/2014
Labeler - Centurion Labs, LLC (806756461)
Registrant - Centurion Labs, LLC (806756461)

Revised: 11/2014
Document Id: 3804bfa6-1470-402f-9577-3f6f2616ff1e
Set id: 7c7dbac3-dd9e-d03a-1303-3d2a207c751b
Version: 3
Effective Time: 20141120
 
Centurion Labs, LLC