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Vanacof Cp Allergy / Cough
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- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/15 mL
- Pyrilamine Maleate 25 mg/15 mL
- Other brand names
- Dosage form
- Solution
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2023
- Label revision date
- October 14, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Chlophedianol Hydrochloride 12.5 mg/15 mL
- Pyrilamine Maleate 25 mg/15 mL
- Other brand names
- Dosage form
- Solution
- 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 2023
- Label revision date
- October 14, 2025
- Manufacturer
- GM Pharmaceuticals, INC
- Registration number
- M012
- NDC root
- 58809-189
- 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
VANACOF® CP is a medication designed to help relieve symptoms associated with allergies and the common cold. It contains two active ingredients: chlophedianol HCl, which acts as a cough suppressant, and pyrilamine maleate, an antihistamine that helps alleviate allergy symptoms. This combination works to temporarily relieve issues such as a runny nose, sneezing, itchy or watery eyes, and cough caused by minor throat and bronchial irritation.
This product is alcohol-free, sugar-free, gluten-free, and dye-free, making it a suitable option for many individuals looking for relief from upper respiratory allergies and cold symptoms.
Uses
If you're dealing with the discomfort of a common cold, hay fever, or other upper respiratory allergies, this medication can help. It temporarily relieves bothersome symptoms such as a runny nose, sneezing, and itching in your nose or throat. You may also find relief from itchy, watery eyes and a cough caused by minor irritation in your throat and bronchial area.
Rest assured, this medication has not been associated with any teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. So, you can use it with confidence to ease your allergy symptoms.
Dosage and Administration
When taking this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 and older, you should take 30 mL (which is equivalent to 2 tablespoons) every 6 to 8 hours. However, make sure not to exceed a total of 120 mL (or 8 tablespoons) in a 24-hour period.
If the patient is a child between the ages of 6 and under 12, the dosage is reduced to 15 mL (1 tablespoon) every 6 to 8 hours, with a maximum of 60 mL (4 tablespoons) in a day. For children under 6 years old, it’s crucial to consult a doctor before administering any dosage. Remember, you should never take more than 4 doses within a 24-hour period to avoid potential risks.
What to Avoid
It's important to use this medication responsibly to ensure your safety. Avoid consuming alcoholic drinks while using this medication, as alcohol can increase drowsiness, especially when combined with sedatives or tranquilizers.
Make sure not to exceed the recommended dosage, as marked drowsiness may occur. If you need to drive a motor vehicle or operate machinery, exercise caution, as this medication can impair your ability to do so safely. Always prioritize your well-being and follow these guidelines closely.
Side Effects
You may experience marked drowsiness while using this product, which can be worsened by alcohol, sedatives, or tranquilizers. It's important to be cautious when driving or operating machinery. Some individuals, particularly children, may also feel more excitable.
If you notice nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within 7 days, please consult a doctor. Additionally, seek medical advice if you develop new symptoms, a fever, rash, or a persistent headache. If you have a chronic cough, glaucoma, difficulty urinating due to an enlarged prostate, or breathing issues like emphysema or chronic bronchitis, talk to your doctor before using this product. In case of overdose, seek medical help immediately or contact a Poison Control Center.
Warnings and Precautions
Before using this product, it's important to consult your doctor if you have a chronic cough (like those caused by smoking, asthma, or emphysema), glaucoma, difficulty urinating due to an enlarged prostate, a cough with excessive mucus, or breathing issues such as emphysema or chronic bronchitis. Additionally, if you are taking sedatives or tranquilizers, please check with your doctor first.
While using this product, make sure to follow the dosage instructions carefully and avoid alcohol, as it can increase drowsiness. Be aware that marked drowsiness may occur, and this can be heightened if you are also taking sedatives or tranquilizers. Exercise caution when driving or operating machinery, and note that excitability may happen, particularly in children.
You should stop using the product and contact your doctor if you experience nervousness, dizziness, or sleeplessness, if your symptoms do not improve within 7 days, or if they recur with fever, rash, or a persistent headache. A persistent cough could indicate a more serious condition. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately.
Overdose
If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.
Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy, and remember that acting quickly can make a significant difference in your health and safety.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
If you have a child under 6 years old, it's important to consult a doctor before giving them this medication. For children aged 6 to under 12 years, the recommended dosage is 15 mL (1 tablespoon) every 6 to 8 hours, but do not exceed 60 mL (4 tablespoons) in a 24-hour period.
For children 12 years and older, the dosage is 30 mL (2 tablespoons) every 6 to 8 hours, with a maximum of 120 mL (8 tablespoons) in 24 hours. Please be aware that some children may experience excitability as a side effect. Always follow these guidelines to ensure your child's safety and well-being.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.
Storage and Handling
To ensure the safety and effectiveness of your product, store it at a temperature between 20° to 30°C (68° to 86°F). This temperature range helps maintain the product's quality. When handling the product, check for a tamper-evident foil seal under the cap. If the foil seal is broken or missing, do not use the product, as this could indicate contamination or that it has been compromised.
By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.
Additional Information
No further information is available.
FAQ
What is VANACOF® CP used for?
VANACOF® CP is used to temporarily relieve symptoms due to the common cold, hay fever, or other upper respiratory allergies, including runny nose, sneezing, and cough.
What are the active ingredients in VANACOF® CP?
Each 15 mL contains 12.5 mg of Chlophedianol HCl, a cough suppressant, and 25 mg of Pyrilamine Maleate, an antihistamine.
Is VANACOF® CP safe for children?
For children 6 to under 12 years, the dose is 15 mL every 6 to 8 hours, not to exceed 60 mL in 24 hours. Consult a doctor for children under 6 years.
What should I avoid while taking VANACOF® CP?
Avoid alcoholic drinks, as they may increase drowsiness. Be cautious when driving or operating machinery.
What are the side effects of VANACOF® CP?
Possible side effects include marked drowsiness and excitability, especially in children. If you experience nervousness, dizziness, or sleeplessness, stop use and consult a doctor.
Can I take VANACOF® CP if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, consult a health professional before use.
What is the maximum dosage for adults?
Adults and children 12 years and older should take 30 mL every 6 to 8 hours, not exceeding 120 mL in 24 hours.
What should I do in case of an overdose?
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Is VANACOF® CP free from common allergens?
Yes, VANACOF® CP is alcohol-free, sugar-free, gluten-free, and dye-free.
Packaging Info
Below are the non-prescription pack sizes of Vanacof Cp Allergy / Cough (chlophedianol hcl, pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution |
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Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Vanacof Cp Allergy / Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
Each 15 mL (1 TBSP) contains Chlophedianol HCl 12.5 mg and Pyrilamine Maleate 25 mg. The formulation is alcohol-free, sugar-free, gluten-free, and dye-free.
Uses and Indications
This drug is indicated for the temporary relief of symptoms associated with the common cold, hay fever, or other upper respiratory allergies. The specific symptoms that this drug alleviates include runny nose, itching of the nose or throat, sneezing, itchy and watery eyes, and cough due to minor throat and bronchial irritation.
There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.
Dosage and Administration
The recommended dosage for the medication is as follows, or as directed by a healthcare professional.
For adults and children aged 12 years and older, the dosage is 30 mL (2 tablespoons) every 6 to 8 hours, with a maximum limit of 120 mL (8 tablespoons) within a 24-hour period.
For children aged 6 to under 12 years, the dosage is 15 mL (1 tablespoon) every 6 to 8 hours, not to exceed 60 mL (4 tablespoons) in a 24-hour period.
For children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.
It is important to note that no more than 4 doses should be taken in any 24-hour period.
Contraindications
Use of this product is contraindicated in the following situations:
Alcohol consumption is contraindicated due to the potential for increased drowsiness when combined with this product.
The use of sedatives and tranquilizers is contraindicated as they may exacerbate drowsiness.
Patients should not exceed the recommended dosage, as doing so may lead to marked drowsiness.
Caution is advised when driving or operating machinery, as drowsiness may impair the ability to perform these tasks safely.
Warnings and Precautions
Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific medical conditions. Prior to use, it is essential to consult a physician if the patient presents with any of the following:
A chronic cough, which may be associated with smoking, asthma, or emphysema.
Glaucoma.
Difficulty urinating due to prostate gland enlargement.
A cough accompanied by excessive phlegm (mucus).
Breathing issues such as emphysema or chronic bronchitis.
Additionally, patients currently taking sedatives or tranquilizers should seek medical advice before using this product.
When administering this product, it is critical to adhere to the recommended dosage and avoid exceeding the directed amount. Patients should refrain from consuming alcoholic beverages, as this may exacerbate drowsiness. Marked drowsiness is a potential side effect, and the concurrent use of alcohol, sedatives, or tranquilizers may further enhance this effect. Caution is advised when driving or operating machinery, as excitability may also occur, particularly in pediatric patients.
Patients should be instructed to discontinue use and consult a physician if they experience nervousness, dizziness, or sleeplessness. If symptoms do not improve within seven days, recur, or are accompanied by fever, rash, or persistent headache, medical advice should be sought. A persistent cough may indicate a serious underlying condition, warranting further evaluation. Any new symptoms that arise should also prompt a consultation with a healthcare provider.
In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.
Side Effects
Marked drowsiness may occur in patients using this product, particularly when combined with alcohol, sedatives, or tranquilizers, which can further increase drowsiness. Patients are advised to exercise caution when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Additionally, excitability has been reported, especially in children.
Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. If symptoms do not improve within 7 days, recur, or are accompanied by fever, rash, or persistent headache, medical advice should be sought. A persistent cough may indicate a serious underlying condition, warranting further evaluation. New symptoms that arise during treatment should also prompt a consultation with a healthcare provider.
Before using this product, patients should seek medical advice if they have a chronic cough associated with smoking, asthma, or emphysema, glaucoma, difficulty urinating due to prostate gland enlargement, a cough with excessive phlegm, or any breathing problems such as emphysema or chronic bronchitis.
In the event of an overdose, it is crucial to obtain medical assistance or contact a Poison Control Center immediately.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Vanacof Cp Allergy / Cough (chlophedianol hcl, pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 6 years of age should consult a doctor before use. For children aged 6 to under 12 years, the recommended dosage is 15 mL (1 tablespoon) every 6 to 8 hours, with a maximum of 60 mL (4 tablespoons) in a 24-hour period. In contrast, adults and children 12 years of age and older may take 30 mL (2 tablespoons) every 6 to 8 hours, not exceeding 120 mL (8 tablespoons) per 24 hours.
It is important to note that excitability may occur, particularly in children.
Geriatric Use
There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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 prescribing information.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.
Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.
Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.
Postmarketing Experience
Postmarketing experience has revealed reports of several adverse reactions associated with the use of the product. These include nervousness, dizziness, sleeplessness, and excitability, particularly noted in pediatric populations. These events were reported voluntarily or identified through surveillance programs.
Patient Counseling
Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed that if their symptoms do not improve within 7 days, recur, or are accompanied by a fever, rash, or persistent headache, they should seek medical advice. A persistent cough may indicate a serious condition, warranting further evaluation.
When using this product, patients must be cautioned not to exceed the recommended dosage and to avoid consuming alcoholic beverages. They should be made aware that marked drowsiness may occur, and that the use of alcohol, sedatives, and tranquilizers can enhance this drowsiness. Patients should exercise caution when driving or operating machinery due to the potential for drowsiness. It is also important to inform patients that excitability may occur, particularly in children.
Healthcare providers should encourage patients to consult a doctor prior to use if they have a cough that is chronic or lasts for an extended period, such as those associated with smoking, asthma, or emphysema. Patients with glaucoma, difficulty urinating due to prostate gland enlargement, a cough that produces excessive phlegm, or breathing problems like emphysema or chronic bronchitis should also seek medical advice before using this product.
Storage and Handling
The product is supplied in a configuration that includes a tamper-evident foil seal under the cap. It is essential to ensure that the foil seal is intact before use; the product should not be utilized if the seal is broken or missing.
For optimal storage, the product should be maintained at a temperature range of 20° to 30°C (68° to 86°F). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Vanacof Cp Allergy / Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.