Akin Cough Formula Dm

Description

Akin Cough Formula is presented in a liquid dosage form, specifically in a 118 ml bottle. The formulation is designed for the management of cough symptoms. The effective date of this product is August 17, 2022.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold or inhaled irritants. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 10 ml (equivalent to 2 teaspoonfuls) every 4 hours, or as directed by a healthcare professional. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should ensure that patients adhere to the specified dosing guidelines to promote safety and efficacy.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain about the presence of an MAOI in their current medication regimen.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Patients uncertain about their medication status regarding MAOIs are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should exercise caution and recommend that patients seek medical advice before using this product if they have a persistent cough or a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider.

Patients are instructed to discontinue use and contact their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain about their current medications.

Common adverse reactions may include a persistent cough that lasts longer than 7 days, recurs, or is accompanied by fever, rash, or headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience these signs.

Additionally, patients should consult a healthcare provider prior to using this product if they have a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current medication regimen. This precaution is critical to avoid potential adverse effects associated with the interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Akin Cough Formula Dm (dextromethorphan, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 10 ml (2 teaspoonfuls) every 4 hours, or as directed by a healthcare professional.

It is essential to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual patient factors may influence treatment outcomes. Regular monitoring and assessment of the patient's response to therapy are advised, particularly in the absence of specific guidelines 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 health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for effective treatment and follow-up care.

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

No postmarketing experience details are available in the insert text.

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 crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their current prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition. Furthermore, patients should be advised to seek medical advice before using this product if they have a cough that is chronic, such as those associated with smoking, asthma, chronic bronchitis, or emphysema. It is also important to recommend that patients consult a doctor if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the seal under the cap before use; do not utilize the product if the seal is torn, broken, or missing.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). Proper handling and storage conditions are crucial to ensure 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 Akin Cough Formula Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)