Ninjacof Cotton Candy Flavor- 16 Oz
FDA Label NDC 79804-032

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eagle Labs Inc. for the product Ninjacof Cotton Candy Flavor- 16 Oz (NDC 79804-032). 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 active ingredient, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Chlophedianol HCL; Antitussive

Pryilamine Maleate; Antihstamine

Uses

Temporarily relieves these symptoms due to the common cold, hayfever, (allergic rhinitis) or other upper respiratroy allergies.

  • Cough due to minor throat and bronchial irritation
  • Runny Nose
  • Sneezing
  • Itching of the Nose or Throat
  • Itchy, watery eyes

Warnings

Do not exceed recommended dosage.
DO NOT USE IF PRINTED SAFETY SEAL IS MISSING OR BROKEN.
Do not use this product
If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain
drugs for depression, psychiatric, or emotional conditions or Parkinsons disease),
or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription
drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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 (mucus)
Ask doctor or pharmacist before use if you are
Taking sedatives or tranquilizers
If you have a breathing problem such as emphysema or chronic bronchitis
If you have glaucoma
If you have difficulty in urination due to enlargement of the prostate gland

When Using This Product

Excitability may occur, especially in children.
Marked drowsiness may occur
Avoid alcoholic drinks
Alcohol, sedatives, and tranquilizers may increase drowsiness
Be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

Nervousness, dizziness, or sleeplessness occurs
Symptoms do not improve within 7 days or are
accompanied by a fever, rash, or persistent headache. A
persistent cough may be a sign of a serious condition.
New symptoms occur

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison
Control Center right away

Directions

Do not exceed recommended dosage.
In case of overdose, get medical help or contact a Poison
Control Center right away


Adults and children
12 years of age
and over: 2 teaspoonfuls (10mL) every 6 to 8
hours not to exceed 8 teaspoons in
24hr


Children 6 to under
12 years of age:1 teaspoonfuls (5ml) every 6 to 8
hours not to exceed 4 teaspoons in
24hr


Children under
6 years of age: Consult a doctor.

Other

Store at 20° - 25°C (68°- 77°F); excursions permitted to 15°-30°C
(59° - 86°F). [See USP Controlled Room Temperature].

Inactive Ingredients

Citric Acid, Glycerin, Natural & Artificial Flavors, Propylene Glycol,
Purified Water, Sodium Benzoate, Sodium Citrate, Sucralose

Questions? Comments?

To report a serious adverse event or obtain product
information, contact 1-866-959-4880

* Please review the disclaimer below.