Novalgina

Description

The available information does not provide specific details regarding the Description section for SPL code 34089-3. Consequently, a comprehensive description cannot be formulated at this time. Further data regarding the drug's chemical composition, molecular weight, dosage form, or other relevant characteristics would be necessary to create an accurate and informative description.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 10 mL (2 teaspoons) administered every 6 hours. For children aged 6 to under 12 years, the appropriate dosage is 5 mL (1 teaspoon) every 6 hours.

It is imperative that the total number of doses does not exceed 6 in any 24-hour period. The medication should not be used in children under 6 years of age.

Healthcare professionals should ensure that patients are advised on the correct measurement and administration techniques to promote safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in the following situations:

Children under 3 years of age should not be given this product, and it should not be used for more than 10 days unless directed by a physician. The concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as for 2 weeks following the cessation of MAOI therapy, due to the risk of serious interactions.

Patients with chronic pulmonary disease or those experiencing shortness of breath should not use this product unless directed by a healthcare professional.

Additionally, adults should not exceed 6 doses in a 24-hour period, and children should not exceed 5 doses in the same timeframe. The use of this product is contraindicated if the patient consumes 3 or more alcoholic drinks daily or if it is taken in conjunction with other medications containing acetaminophen. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare provider is advised.

Warnings and Precautions

Severe liver damage may occur if the recommended dosage of this product is exceeded. It is imperative that adults do not take more than 6 doses within a 24-hour period, and children should not exceed 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing Acetaminophen, as this can lead to unintentional overdose.

Individuals consuming 3 or more alcoholic drinks daily should avoid using this product, as the risk of liver damage is significantly heightened. This product is contraindicated in children under 3 years of age and should not be used for more than 10 days unless directed by a physician.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease should not use this product, nor should they do so for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, consultation with a healthcare provider is recommended prior to use.

Individuals with chronic pulmonary diseases or those experiencing shortness of breath should only use this product under medical supervision. Alcoholic beverages should be avoided during the course of treatment. Additionally, it is crucial to refrain from using this product alongside any other medications containing Acetaminophen, whether prescription or nonprescription. If there is any doubt about the presence of Acetaminophen in a medication, a healthcare professional should be consulted.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. A cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache warrants immediate medical evaluation, as it may indicate a serious underlying condition.

In the event of an overdose, it is essential to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Severe liver damage may occur if the recommended dosage of this product, which contains Acetaminophen, is exceeded. Patients should be advised to consult a healthcare professional prior to use if they have a cough that occurs with excessive phlegm, a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals with heart disease, high blood pressure, thyroid disease, or those experiencing difficulty in urination due to prostate gland enlargement should seek medical advice before using this product.

Patients with liver diseases should also exercise caution, as the use of this product may pose additional risks. Furthermore, individuals taking the blood-thinning medication Warfarin are advised to consult their healthcare provider prior to use, as potential interactions may occur.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on a prescription MAOI or for a period of two weeks following the discontinuation of an MAOI. This is due to the potential for serious interactions that may lead to adverse effects.

Additionally, caution is advised when this medication is used in patients who are concurrently taking warfarin, a blood-thinning agent. The interaction may necessitate careful monitoring of coagulation parameters to ensure that the anticoagulant effect of warfarin remains within the therapeutic range. Adjustments to the warfarin dosage may be required based on clinical judgment and laboratory results.

Packaging & NDC

Below are the non-prescription pack sizes of Novalgina (acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 3 years of age should not be administered this medication, and its use for more than 10 days is not recommended unless directed by a physician.

For children aged 6 to under 12 years, the recommended dosage is 5 ml (1 teaspoon) every 6 hours.

The medication is contraindicated in children under 6 years of age.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 should be closely monitored due to the potential risk of severe liver damage associated with the use of this product, which contains Acetaminophen. It is critical that the recommended dosage is not exceeded, as doing so may lead to significant adverse effects on liver function.

Healthcare providers are advised to assess liver function prior to initiating treatment and to consider dosage adjustments based on the severity of hepatic impairment. Regular monitoring of liver enzymes may be warranted to ensure patient safety and to mitigate the risk of hepatotoxicity.

Overdosage

In cases of overdosage, specific guidelines and symptoms must be considered to ensure appropriate management and intervention.

Dosage Exceedance An adult who ingests more than six doses within a 24-hour period exceeds the maximum recommended daily amount. For children, the threshold is more than five doses in the same timeframe. It is critical to monitor for potential symptoms of overdosage in these scenarios.

Drug Interactions Overdosage may occur if the product is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients to avoid using this product alongside any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider or pharmacist is recommended.

Alcohol Consumption Patients who consume three or more alcoholic drinks daily while using this product are at increased risk for adverse effects. It is advised to avoid alcoholic beverages entirely during the course of treatment with this product.

Contraindications The product should not be administered to children under three years of age or used for more than ten days unless directed by a physician. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have ceased MAOI treatment within the last two weeks should not use this product. Patients should be encouraged to verify with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Pre-existing Conditions Patients with chronic pulmonary diseases or those experiencing shortness of breath should only use this product under medical supervision.

In the event of suspected overdosage, immediate medical attention should be sought, and healthcare professionals should be prepared to provide supportive care and symptomatic treatment as necessary.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, a persistent cough has been noted, which may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this medication should not be given to children under 3 years of age and should not be used for more than 10 days unless directed by a physician. Patients should also be cautioned against consuming alcoholic beverages while taking this product, as it may increase the risk of adverse effects.

Patients should be encouraged to verify with their doctor or pharmacist whether their prescription drug contains a monoamine oxidase inhibitor (MAOI) before taking this product. Additionally, they should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult their doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Furthermore, patients should be advised to stop using the medication and consult a doctor if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Storage and Handling

The product is supplied with a tamper evident feature; it should not be used if the seal under the cap is torn, broken, or missing.

For optimal storage, the product must be maintained at a temperature range of 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Novalgina, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)