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.
Updated November 20, 2014
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- ACTIVE INGREDIENT
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
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
- When using this product
- Stop use and ask a doctor if
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.
Directions Do not exceed recommended dosage. Use calibrated measuring device for administering the drug to a child.
Adults and children
12 years of age
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.
6 years of age:
Consult a doctor
- Other Information
- Inactive Ingredients
- Questions? Comments?
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
PRINCIPAL DISPLAY PANEL
Pain Reliever • Fever Reducer • Antitussive • Anithistamine
Each teaspoonful (5mL) Contains:
Alcohol Free • Dye Free • Sugar Free
16 fl oz (473 mL)
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:23359-033 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg in 5 mL 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 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 Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23359-033-16 473 mL in 1 BOTTLE 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 (806756461) Registrant - Centurion Labs, LLC (806756461)