Label: NINJACOF-A- ninjacof-a 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    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:

    • cough due to minor throat and bronchial irritation
    • calms the cough control center and relieves coughing
    • itching of the nose or throat
    • itchy, watery eyes
    • minor aches and pains
    • temporarily reduces fever
    • runny nose
    • sneezing
    • headache
  • Warnings

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

    • adult takes more than 6 teaspoonfuls in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks everyday while using this product
    • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
    • May cause excitability especially in children
  • Ask a doctor or pharmacist before you use

    • if you are taking sedatives or tranquilizers
    • if the user has liver disease
    • if user is taking the blood thinning drug warfarin
    • if cough persists for more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache.

    A persistent cough may be a sign of a serious condition

  • When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery
  • Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
    • new symptoms occur
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of serious condition.

  • DO NOT USE

    • with any other drug containing Acetaminophen (perscription or nonprescription).
    • if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this product.
    • unless directed by a doctor, if you have breathing problems such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to an enlargement of the prostate gland or for persistent or chronic cough such as occcurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

    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.

  • TERATOGENIC EFFECTS

    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

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

  • 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
  • INGREDIENTS AND APPEARANCE
    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)