Label: NINJACOF-XG- codeine phosphate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 20, 2014

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  • ACTIVE INGREDIENT

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

    Uses  Temporarily relieves:

    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • WARNINGS AND PRECAUTIONS

    Warnings
    Do not exceed recommended dosage.
    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 (mucas)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • STOP USE

    Stop use and ask a doctor if

    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
    • new symptoms occur
    • product may cause or aggravate constipation
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INSTRUCTIONS FOR USE

    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.
  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • PURPOSE

  • WARNINGS

  • DOSAGE & ADMINISTRATION

  • QUESTIONS

    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
  • INGREDIENTS AND APPEARANCE
    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)
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