Ninjacof Cotton Candy Flavor- 16 oz

Manufacturer
Eagle Labs Inc.
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:11:05

Label at a glance#

ProductNinjacof Cotton Candy Flavor- 16 oz
Active ingredientPYRILAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE
Label structure13 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlophedianol HCL

Pryilamine Maleate

Purpose

OTC - PURPOSE SECTION

Anitussive

Antihistamine

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions? Comments?

OTC - QUESTIONS SECTION

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

Ninjacof Cotton Candy Flavor 16 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ninjacof 16ozNinjacof 16oz

Ninjacof Cotton Candy Flavor 4 oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ninjacof 4ozNinjacof 4oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1593749chlophedianol HCl 12.5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral SolutionPSN4
1593756Ninjacof 12.5 MG / 12.5 MG in 5 mL Oral SolutionPSN4
1593756chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral Solution [Ninjacof]SBD4
1593749chlophedianol hydrochloride 2.5 MG/ML / pyrilamine maleate 2.5 MG/ML Oral SolutionSCD4
1593749chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral SolutionSY4
1593756Ninjacof (chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 12.5 MG) per 5 ML Oral SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79804-032-01Ninjacof Cotton Candy Flavor- 16 oz10 mL in 1 BOTTLE, PLASTICLIQUID104
79804-032-04Ninjacof Cotton Candy Flavor- 16 oz118 mL in 1 BOTTLE, PLASTICLIQUID1184
79804-032-16Ninjacof Cotton Candy Flavor- 16 oz473 mL in 1 BOTTLE, PLASTICLIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79804-032NINJACOF COTTON CANDY FLAVOR- 16 OZ (ANTITUSSIVE AND ANTIHISTAMINE) LIQUID [EAGLE LABS INC.]4Legacy NDC, 3 package rows20240417_a624be5f-c8b5-4105-bb87-4cd0c0e9edfb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79804-03279804-032-16, 79804-032-04, 79804-032-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16235cd7-a287-2c96-e063-6294a90a806ba624be5f-c8b5-4105-bb87-4cd0c0e9edfb2024-04-15WarningsExact identifier
spl id: 16235cd7-a287-2c96-e063-6294a90a806b
spl set id: a624be5f-c8b5-4105-bb87-4cd0c0e9edfb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.