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Ninjacof Cotton Candy Flavor- 16 Oz
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This product has been discontinued
- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/5 mL
- Pyrilamine Maleate 12.5 mg/5 mL
- Other brand names
- Dosage form
- Liquid
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2021
- Label revision date
- April 15, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/5 mL
- Pyrilamine Maleate 12.5 mg/5 mL
- Other brand names
- Dosage form
- Liquid
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2021
- Label revision date
- April 15, 2024
- Manufacturer
- Eagle Labs Inc.
- Registration number
- M012
- NDC root
- 79804-032
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Ninjacof Cotton Candy Flavor is a medication designed to temporarily relieve symptoms associated with the common cold, hay fever (allergic rhinitis), and other upper respiratory allergies. It helps alleviate discomfort caused by minor throat and bronchial irritation, as well as symptoms like a runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes.
This product works by targeting the underlying causes of these symptoms, providing you with relief when you need it most. If you're experiencing any of these common issues, Ninjacof may be a helpful option to consider.
Uses
If you're dealing with the discomfort of a common cold, hay fever (also known as allergic rhinitis), or other upper respiratory allergies, this medication can help. It temporarily relieves symptoms such as a cough caused by minor irritation in your throat and bronchial tubes, a runny nose, sneezing, and itching in your nose or throat. You may also find relief from itchy, watery eyes.
It's important to note that this medication has not been associated with teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about these specific risks.
Dosage and Administration
When taking this medication, adults and children aged 12 years and older should take 2 teaspoonfuls (10 mL) every 6 to 8 hours. However, make sure not to exceed 8 teaspoonfuls in a 24-hour period. For children aged 6 to under 12 years, the recommended dose is 1 teaspoonful (5 mL) every 6 to 8 hours, with a maximum of 4 teaspoonfuls in a day.
If your child is under 6 years old, it’s important to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.
What to Avoid
You should avoid using this medication if you have a chronic cough, such as one caused by smoking, asthma, or emphysema, or if your cough produces excessive mucus. It's also important not to use it if you have breathing issues like emphysema or chronic bronchitis, glaucoma, or difficulty urinating due to an enlarged prostate.
Be cautious about mixing this medication with alcohol, sedatives, or tranquilizers, as these can increase drowsiness. Always consult your doctor before using this medication if you are taking sedatives or tranquilizers. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within 7 days, or if you develop a fever, rash, or persistent headache, stop using the medication and seek medical advice. A persistent cough may indicate a serious health issue, so it's essential to pay attention to any new symptoms that arise.
Side Effects
It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if your symptoms do not improve within 7 days, or if they are accompanied by a fever, rash, or a persistent headache, seek medical advice. A persistent cough could indicate a more serious condition, so it's best to get it checked out.
Always ensure you do not exceed the recommended dosage and avoid using the product if the safety seal is missing or broken. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, do not use this product, and wait at least 2 weeks after stopping the MAOI before using it. If you're unsure whether your medication contains an MAOI, consult your doctor or pharmacist.
Warnings and Precautions
It's important to use this product safely. Always follow the recommended dosage and do not use it if the safety seal is missing or broken. Avoid this product if you are currently taking certain prescription medications called monoamine oxidase inhibitors (MAOIs), which are used for depression or other mental health conditions, or if you have stopped taking them within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.
Be cautious if you have a chronic cough, especially if it's related to smoking, asthma, or emphysema, or if you have a cough with excessive mucus. It's also wise to check with your doctor or pharmacist before using this product if you take sedatives or tranquilizers, have breathing issues like emphysema or chronic bronchitis, have glaucoma, or experience difficulty urinating due to an enlarged prostate.
If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days, especially if accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor. Additionally, if you notice any new symptoms or suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately.
Overdose
Taking more than the recommended dosage of a medication can lead to serious health risks. It's important to always follow the dosage instructions provided by your healthcare provider or on the medication label. Exceeding this amount can result in an overdose, which may cause harmful effects.
If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always err on the side of caution—if you are unsure or feel unwell after taking your medication, contact a healthcare professional right away.
Pregnancy Use
If you are pregnant or planning to become pregnant, it is important to avoid using this product unless your doctor specifically advises you to do so. The safety of this product during pregnancy has not been established, which means there may be risks to your developing baby.
Additionally, if you are breastfeeding, you should consult your doctor before using this product. Always prioritize your health and the health of your baby by discussing any medications or treatments with your healthcare provider.
Lactation Use
If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Ninjacof Cotton Candy Flavor for nursing mothers. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.
Pediatric Use
When giving this medication to children aged 6 to under 12 years, you should administer 1 teaspoonful (5 mL) every 6 to 8 hours, but be careful not to exceed 4 teaspoons in a 24-hour period. For children under 6 years old, it's important to consult a doctor before use to ensure safety.
Be aware that some children may experience excitability or marked drowsiness while taking this medication. Always monitor your child for any unusual reactions and discuss any concerns with your healthcare provider.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help you understand any necessary precautions or adjustments based on your kidney health.
Hepatic Impairment
If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.
Drug Interactions
It's important to be cautious when using this product, especially if you are currently taking or have recently stopped certain medications. Specifically, you should not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or Parkinson's disease. You should also wait at least two weeks after stopping an MAOI before using this product.
Additionally, be aware that consuming alcohol, sedatives, or tranquilizers while using this product may increase feelings of drowsiness. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.
Storage and Handling
To ensure the best performance of your product, store it at a temperature between 20° and 25°C (68° and 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it as close to the recommended range as possible.
When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for use to ensure safety and effectiveness.
Additional Information
You will take this medication orally. It's important to be aware that excitability may occur, particularly in children, and you might experience marked drowsiness. To ensure your safety, avoid alcoholic drinks, as well as sedatives and tranquilizers, since these can increase drowsiness. Be cautious when driving or operating machinery.
If you notice nervousness, dizziness, or sleeplessness, stop using the medication and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if you develop a fever, rash, or persistent headache, seek medical advice. A persistent cough could indicate a more serious condition, so pay attention to any new symptoms that arise.
FAQ
What is Ninjacof Cotton Candy Flavor used for?
Ninjacof Cotton Candy Flavor temporarily relieves symptoms due to the common cold, hayfever (allergic rhinitis), or other upper respiratory allergies, including cough, runny nose, sneezing, and itchy eyes.
What is the recommended dosage for adults and children over 12?
Adults and children 12 years of age and over should take 2 teaspoonfuls (10 mL) every 6 to 8 hours, not exceeding 8 teaspoons in 24 hours.
What should children aged 6 to under 12 take?
Children 6 to under 12 years of age should take 1 teaspoonful (5 mL) every 6 to 8 hours, not exceeding 4 teaspoons in 24 hours.
Is Ninjacof safe for children under 6?
Consult a doctor before giving Ninjacof to children under 6 years of age.
What are the contraindications for using Ninjacof?
Do not use Ninjacof if you have a chronic cough, breathing problems like emphysema, glaucoma, or difficulty urinating due to prostate enlargement.
What should I do if I experience nervousness or dizziness while taking Ninjacof?
Stop using Ninjacof and consult a doctor if you experience nervousness, dizziness, or sleeplessness.
Can I use Ninjacof if I am pregnant?
Do not use Ninjacof if you are pregnant or planning to become pregnant unless directed by a doctor.
What precautions should I take while using Ninjacof?
Avoid alcoholic drinks, as alcohol and sedatives may increase drowsiness. Be cautious when driving or operating machinery.
What should I do in case of an overdose?
In case of overdose, get medical help or contact a Poison Control Center immediately.
What storage conditions are recommended for Ninjacof?
Store Ninjacof at 20° - 25°C (68°- 77°F), with excursions permitted to 15°-30°C (59° - 86°F).
Packaging Info
Below are the non-prescription pack sizes of Ninjacof Cotton Candy Flavor- 16 Oz (antitussive and antihistamine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Ninjacof Cotton Candy Flavor- 16 Oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Ninjacof Cotton Candy Flavor is presented in a 16 oz container. The effective time for this product is noted as November 17, 2022. The observation media associated with this product is an image file, specifically in JPEG format, labeled as Ninjacof 16oz. The reference value for this product is also identified as Ninjacof 16oz.jpg.
Uses and Indications
This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies. Specifically, it alleviates the following symptoms:
Cough due to minor throat and bronchial irritation
Runny nose
Sneezing
Itching of the nose or throat
Itchy, watery eyes
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
For adults and children aged 12 years and over, the recommended dosage is 2 teaspoonfuls (10 mL) administered every 6 to 8 hours. The total daily dosage should not exceed 8 teaspoonfuls (40 mL) within a 24-hour period.
For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 6 to 8 hours, with a maximum limit of 4 teaspoonfuls (20 mL) in a 24-hour period.
For children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.
Administration should be performed using a proper measuring device to ensure accurate dosing.
Contraindications
Use of this product is contraindicated in the following situations:
Patients with a chronic cough, including those associated with smoking, asthma, or emphysema, should not use this product due to the potential for exacerbation of their condition. Additionally, individuals experiencing a cough with excessive phlegm (mucus) should avoid use, as this may indicate an underlying issue requiring medical attention.
This product is also contraindicated in patients with respiratory conditions such as emphysema or chronic bronchitis, as it may worsen their breathing difficulties. Furthermore, individuals with glaucoma should not use this product due to the risk of increased intraocular pressure.
Patients with urinary retention due to prostate gland enlargement should avoid this product, as it may exacerbate their condition.
Lastly, the consumption of alcoholic beverages is contraindicated, as it may enhance drowsiness when combined with this product.
Warnings and Precautions
It is imperative to adhere to the recommended dosage when using this product. Exceeding the prescribed amount may lead to adverse effects. Additionally, the product must not be used if the printed safety seal is missing or broken, as this indicates potential tampering.
This product is contraindicated for individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications used for depression, psychiatric conditions, or Parkinson's disease. It is also advised to refrain from using this product for at least two weeks after discontinuing an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in any prescription medication.
General precautions should be observed, particularly in patients with a chronic cough, such as those associated with smoking, asthma, or emphysema. Coughs accompanied by excessive phlegm warrant caution. Prior to use, patients should consult with a healthcare provider if they are taking sedatives or tranquilizers, or if they have a history of breathing problems, such as emphysema or chronic bronchitis. Special consideration should also be given to individuals with glaucoma or those experiencing difficulty urinating due to prostate gland enlargement.
Patients are advised to discontinue use and contact a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, rash, or persistent headache, medical advice should be sought. A persistent cough may indicate a serious underlying condition, necessitating further evaluation.
In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.
Side Effects
Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, and it is crucial to adhere to the recommended dosage to minimize risks. Patients are advised not to use the product if the printed safety seal is missing or broken. Additionally, the product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, as this may lead to significant interactions.
Common adverse reactions that warrant discontinuation of use and consultation with a healthcare professional include nervousness, dizziness, and sleeplessness. Patients should also seek medical advice if symptoms do not improve within seven days, or if they experience accompanying symptoms such as fever, rash, or persistent headache. Furthermore, a persistent cough may indicate a serious underlying condition, and new symptoms should prompt immediate medical consultation.
Monitoring for these adverse reactions is essential to ensure patient safety and effective management of any potential complications.
Drug Interactions
The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients currently taking MAOIs, which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease, should not use this product. Additionally, it is advised to avoid this product for a period of two weeks following the discontinuation of an MAOI.
Caution is advised when this product is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. Monitoring for increased sedation is recommended in patients who are using these agents concurrently.
Packaging & NDC
Below are the non-prescription pack sizes of Ninjacof Cotton Candy Flavor- 16 Oz (antitussive and antihistamine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Liquid |
| ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients aged 6 to under 12 years may be administered 1 teaspoonful (5 mL) every 6 to 8 hours, with a maximum dosage of 4 teaspoons in a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.
Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported, necessitating caution when monitoring these patients.
Geriatric Use
Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.
Pregnancy
The use of this product is not recommended for pregnant patients or those planning to become pregnant unless directed by a healthcare professional. The safety of this product during pregnancy has not been established, and therefore, potential risks to the fetus cannot be determined. It is essential for women of childbearing potential to consult a healthcare provider before using this product, especially if they are pregnant or breastfeeding.
Lactation
There are no specific warnings or recommendations regarding the use of Ninjacof Cotton Candy Flavor in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
Exceeding the recommended dosage of the medication may lead to serious adverse effects. Healthcare professionals are advised to monitor patients closely for any signs of overdosage.
Symptoms of Overdosage
Patients who have ingested an excessive amount of the medication may exhibit a range of symptoms. These can vary depending on the specific drug involved and the extent of the overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, and cardiovascular instability.
Recommended Actions
In the event of suspected overdosage, immediate medical attention is essential. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is crucial to assess the patient's vital signs and provide appropriate interventions based on the clinical presentation.
Management Procedures
Management of overdosage may involve the use of activated charcoal if the patient presents within a suitable timeframe post-ingestion. Additionally, specific antidotes may be indicated depending on the medication involved. Continuous monitoring and supportive care should be maintained until the patient stabilizes.
Healthcare professionals are reminded to adhere strictly to the recommended dosage guidelines to minimize the risk of overdosage and its associated complications.
Nonclinical Toxicology
No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.
Postmarketing Experience
Serious adverse events have been reported voluntarily or through surveillance programs. For inquiries regarding serious adverse events or to obtain additional product information, individuals are encouraged to contact 1-866-959-4880.
Patient Counseling
Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for healthcare providers to encourage patients to consult with a doctor prior to using this product if they have a cough that is persistent or chronic, such as those associated with smoking, asthma, or emphysema. Patients should also be informed to discuss their condition if they have a cough accompanied by excessive phlegm, are taking sedatives or tranquilizers, have breathing issues like emphysema or chronic bronchitis, suffer from glaucoma, or experience difficulty urinating due to prostate gland enlargement.
Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, rash, or a persistent headache, patients should seek medical advice, as a persistent cough may indicate a serious underlying condition. They should also be advised to report any new symptoms that arise during treatment.
While using this product, patients should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. It is crucial to advise patients to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Patients should also be cautioned to exercise care when driving a motor vehicle or operating machinery due to the potential for drowsiness.
Storage and Handling
The product is supplied in accordance with the following specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° and 30°C (59° to 86°F), as defined by USP Controlled Room Temperature guidelines.
Proper storage conditions are essential to maintain the integrity of the product. It is recommended that the product be kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to ensure the product remains within the specified temperature range throughout its storage period.
Additional Clinical Information
The medication is administered orally. Clinicians should counsel patients on potential side effects, including excitability, particularly in children, and marked drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery.
Patients should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if symptoms do not improve within 7 days, or if they are accompanied by fever, rash, or persistent headache. A persistent cough may indicate a serious condition, and patients should report any new symptoms to their healthcare provider.
Drug Information (PDF)
This file contains official product information for Ninjacof Cotton Candy Flavor- 16 Oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.