NINJACOF-XG - codeine phosphate 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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Ninjacof-XG

*
Warning: May be habit forming
Active ingredients (in each 5 mL)Purpose
Codeine Phosphate*8 mg Antitussive
(Cough Suppressant)
Guaifenesin 200 mg Expectorant

Uses  Temporarily relieves:

Warnings
Do not exceed recommended dosage.
Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a
health professional before use.

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control
Center right away.

Directions  Take this medication with a full glass of water after each dose to help loosen mucus in the lungs

*
Giving a higher dose than recommended by a doctor could result in serious side effects.
Adults and children
12 years of age
and over:
2 teaspoonfuls (10mL) every
4 hours, not to exceed
12 teasoonfuls in 24 hours
Children 6 to under
12 years of age:
1 teaspoonful (5 mL) every
4 hours, not to exceed
6 teaspoonfuls in 24 hours
*Children under
6 years of age:
Consult a doctor.

Other Information
Store at 15° - 30°C (59° - 86°F).

Inactive Ingredients

Bitter Mask, Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

23359-040-16

Ninjacof-XG

Cotton Candy
Flavor

CENTURION

16 fl oz (473 mL)

Tamper evident by foil seal under cap. Do not use if foil
seal is broken or missing.

Dispense in a tight, light-resistant container as defined
in the USP/NF with a child-resistant closure.

Store at controlled room temperature,
15°-30°C (59°-86°F)

KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.

Manufactured for:
Centurion Labs, LLC Birmingham, AL 35243

Ninjacof-XG
NINJACOF-XG  
codeine phosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23359-040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate8 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23359-040-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2014
Labeler - Centurion Labs, LLC (806756461)
Registrant - Centurion Labs, LLC (806756461)

Revised: 11/2014
Document Id: 47ba8466-68bc-4b31-89c9-6340dff26e9a
Set id: 98f8bf79-825d-c04d-0edd-826d4752736d
Version: 3
Effective Time: 20141120
 
Centurion Labs, LLC