Otc - Active Ingredient
| Active ingredients (in each 5 mL) | Purpose |
| Codeine Phosphate Warning: May be habit forming 8 mg | Antitussive (Cough Suppressant) |
| Guaifenesin 200 mg | Expectorant |
Ninjacof-xg
FDA Label NDC 23359-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Centurion Labs, Llc for the product Ninjacof-xg (NDC 23359-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings and precautions, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, instructions for use, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a
health professional before use.
Otc - 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
| 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 |
Giving a higher dose than recommended by a doctor could result in serious side effects. Children under6 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.
Otc - 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 (47ba8466 68bc 4b31 89c9 6340dff26e9a 01)
* Please review the disclaimer below.
