Akin Cough Formula Dm Strawberry Banana

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 facilitating more productive coughs.

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for medical evaluation or treatment of underlying conditions.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. For adults and children aged 12 years and older, the recommended dose is 10 ml (equivalent to 2 teaspoonfuls) administered orally every 4 hours, or as directed by a healthcare professional.

Use of this medication is not recommended for children under 12 years of age. It is important to adhere to the specified dosing intervals to avoid exceeding the maximum daily limit.

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 uncertain about their medication status regarding MAOIs should consult a healthcare professional prior to using this product.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in any current prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance 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 that produces excessive phlegm (mucus) should also consult a healthcare provider.

Patients are instructed to discontinue use and contact their healthcare provider if the 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 that requires medical evaluation.

In the event of an overdose, it is critical 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 the use of this medication. Serious warnings include the contraindication of use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication, as this may lead to significant interactions.

Patients are advised to discontinue use and consult a healthcare professional if a 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 that requires medical attention.

Before initiating treatment, patients should seek medical advice if they have a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

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 use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of 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 before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients 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 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

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

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 the safety of both the mother and the developing fetus.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 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

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

No postmarketing experience details are available in the insert.

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 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. Patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their current medications include an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a healthcare professional 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. Additionally, healthcare providers should recommend that patients seek medical advice before using this product if they have a cough that lasts or if they suffer from chronic cough conditions, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, particularly if the cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F), to maintain its efficacy and safety.

Healthcare professionals are advised to inspect the product prior to use; it must not be utilized if the seal under the cap is torn, broken, or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

The product is administered topically, with a recommended dosage of 10 ml (2 teaspoonfuls) every 4 hours for adults and children aged 12 years and older, or as directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Akin Cough Formula Dm Strawberry Banana, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)