FDA Label for Ninjacof-a
View Indications, Usage & Precautions
Ninjacof-a Product Label
The following document was submitted to the FDA by the labeler of this product Centurion Labs, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
| Active Ingredients (in each 5 mL) | Purposes |
| Acetaminophen 160 mg | Pain Reliever |
| Chlophedianol HCl 12.5 mg | Antitussive |
| Pyrilamine Maleate 12.5mg | Antihistamine |
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
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)
* Please review the disclaimer below.