Acetaminophen Dextromethorphan Hydrobromide and Doxylamine Succinate

Description

VALUMEDS is a multi-symptom nighttime relief formulation designed to address cold and flu symptoms. Each softgel contains a combination of active ingredients, including acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, functioning as a cough suppressant; and doxylamine succinate, an antihistamine. The product is presented in the form of liquid-filled capsules, with a total of 10 softgels per package. This formulation is comparable to the active ingredients found in VICKS® NyQUIL®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, fever, as well as runny nose and sneezing.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is to swallow two softgels with water every six hours.

For children aged 4 to under 12 years, it is advised to consult a physician for appropriate dosing guidance.

The use of this product is not recommended for children under 4 years of age.

When utilizing both Nighttime and Daytime softgels, it is essential to carefully read each label to ensure accurate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI.

• The product should not be used to induce sleep in children.

• Additionally, it is contraindicated to exceed the recommended dosage.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product. Healthcare professionals should advise patients to seek immediate medical attention in the event of an overdose, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to consult a physician prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, it is advisable for patients to discuss their current medications with a healthcare provider or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Patients should be advised to seek medical attention if sore throat symptoms are severe, persist for more than 2 days, or are accompanied by fever, headache, rash, nausea, or vomiting. Furthermore, they should discontinue use and consult a physician if pain or cough worsens or lasts longer than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or headache lasting longer than usual, as these may indicate a serious underlying condition.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4 doses in 24 hours, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients should be advised to seek medical attention if they experience a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. It is also not recommended for use in children to induce sleep.

Patients should consult a healthcare professional prior to use if they have liver disease, glaucoma, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Those experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

While using this product, patients should adhere strictly to the directed dosage. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. Patients are advised to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, given that alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should discontinue use and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

An overdose of this product can lead to serious health complications. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and should be avoided for at least 2 weeks after discontinuation of the MAOI. This combination may lead to serious adverse effects, including hypertensive crises.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects and increase the risk of drowsiness.

Additionally, caution is advised for patients taking the anticoagulant warfarin. The interaction may alter the anticoagulant effect, necessitating careful monitoring of INR levels and potential dosage adjustments.

Alcohol, sedatives, and tranquilizers may further increase drowsiness when used in conjunction with this medication. It is advisable to avoid such combinations to minimize the risk of excessive sedation and impaired cognitive function.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Dextromethorphan Hydrobromide and Doxylamine Succinate (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For adults and children aged 12 years and older, the recommended dosage is to swallow 2 softgels with water every 6 hours.

Caution is advised as excitability may occur, particularly in children. Additionally, marked drowsiness may be experienced in pediatric patients.

Geriatric Use

Elderly patients may be more sensitive to the side effects of this medication, particularly marked drowsiness. Caution is advised when these patients are driving a motor vehicle or operating machinery.

While there is no specific information provided regarding dosage adjustments or safety concerns for geriatric patients, healthcare providers should remain vigilant in monitoring this population for any adverse effects. The medication is indicated for use in adults and children aged 12 years and older, but specific considerations for patients aged 65 and older have not been detailed. Therefore, careful assessment and individualized treatment plans are recommended for elderly patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 4 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients limit alcohol consumption to fewer than 3 drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Patients with known liver disease should consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the effects of an overdose may not be immediately apparent.

Both adults and children are at risk, and quick medical attention is essential, even in the absence of noticeable signs or symptoms. This proactive approach can significantly mitigate the potential adverse effects associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that several adverse reactions have been reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis and angioedema. Instances of liver injury have also been documented, with some cases progressing to acute liver failure. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed. Additionally, gastrointestinal bleeding and renal impairment, including acute kidney injury, have been reported.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be cautioned against using this product to induce sleep in children. They should be instructed to discontinue use and seek medical advice if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be advised to stop use and consult a doctor if a cough recurs or is accompanied by a rash or a persistent headache, as these may indicate a serious condition.

When using this product, patients should be reminded not to exceed the recommended dosage. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Patients should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should exercise caution when driving or operating machinery while using this product. It is essential for patients to consult a doctor before use if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use.

Finally, patients should be encouraged to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older should swallow 2 softgels with water every 6 hours. For children aged 4 to under 12 years, it is advised to consult a doctor before use, while the medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Acetaminophen Dextromethorphan Hydrobromide and Doxylamine Succinate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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