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Akin Expectorant Formula Strawberry Banana

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Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Topical
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
November 29, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Topical
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
November 29, 2023
Manufacturer
Southern Sales & Service, Inc.
Registration number
M012
NDC root
69822-212
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. By doing so, it can assist your body in clearing out mucus from your airways, which may help you breathe easier. If you're dealing with a cough that produces mucus, this drug may be beneficial in managing your symptoms.

Uses

This medication is designed to help you if you're dealing with a cough that produces phlegm (a thick mucus). It works by loosening the phlegm and thinning out bronchial secretions, making it easier for you to cough up the mucus. This can help make your cough more productive, allowing you to clear your airways more effectively.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 to 4 teaspoonfuls (5 mL) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period.

If you are considering this medication for a child under 12 years old, it's essential to consult a physician (a medical doctor) first to determine the appropriate dosage. Always adhere to these guidelines to help manage your health effectively.

What to Avoid

It's important to be aware of when to stop using this medication. If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, you should stop taking it and consult your doctor. A persistent cough could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

You should be aware that this product is not intended for treating persistent or chronic coughs, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, unless your doctor advises otherwise. If your cough lasts more than a week, keeps coming back, or is accompanied by symptoms like fever, rash, or a persistent headache, it's important to stop using the product and consult a doctor, as these could indicate a more serious health issue.

Additionally, keep this product out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

You should avoid using this product if you have a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, especially if your cough comes with a lot of mucus, unless your doctor advises otherwise.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious health issue.

In the event of an overdose, it’s crucial to seek emergency medical help or contact a Poison Control Center immediately. Your health and safety are important, so please take these warnings seriously.

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 typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

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 12 years old, it's important to consult a physician (doctor) before using this medication. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions that often apply to elderly patients are not detailed in the insert.

If you or a caregiver are considering this medication, it’s important to consult with a healthcare professional who can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). This temperature range helps maintain its effectiveness. Before using the product, always check the seal under the cap; do not use it if the seal is torn, broken, or missing, as this could compromise safety and effectiveness.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and reliable for your use.

Additional Information

You should apply this medication topically. For adults and children aged 12 years and older, the recommended dose is 2 to 4 teaspoonfuls (5 mL) every 4 hours. If the patient is under 12 years old, it's important to consult a physician for appropriate guidance.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2-4 teaspoonfuls (5 mL) every 4 hours, but do not exceed 6 doses in any 24-hour period.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than a week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Can children under 12 use this drug?

Children under 12 years should consult a physician before use.

How should I store this drug?

Store at room temperature between 15°-30°C (59°-86°F).

What should I check before using this drug?

Do not use if the seal under the cap is torn, broken, or missing.

Packaging Info

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

Packaging configurations for Akin Expectorant Formula Strawberry Banana.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It 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 facilitation of mucus clearance in patients with respiratory conditions. It helps to loosen phlegm and thin 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 take 2 to 4 teaspoonfuls (5 mL) every 4 hours as needed. 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, consultation with a physician is recommended prior to administration to determine appropriate dosing and safety.

Contraindications

Use is contraindicated in patients with a persistent cough lasting more than one week, or if the cough tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Patients should not use this product for the treatment of persistent or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema, nor in cases where the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare professional.

If a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are advised to discontinue use and consult a healthcare provider. A persistent cough may indicate an underlying serious condition that requires medical evaluation.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is important to note that this product is not intended for use in cases of persistent or chronic cough, such as those resulting from smoking, asthma, chronic bronchitis, or emphysema, or when cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

Patients are advised to discontinue use and consult a doctor if the cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires medical evaluation.

Additionally, this product should be kept out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Akin Expectorant Formula Strawberry Banana.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. 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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 text.

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 for patients to understand the importance of timely intervention in such situations.

Additionally, patients should be informed that if their cough persists for more than a week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, they should consult a doctor. A persistent cough may indicate a serious underlying condition, and early medical evaluation is essential for appropriate management.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F).

Healthcare professionals are advised to ensure that the seal under the cap is intact; the product should not be used if the seal is torn, broken, or missing. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the recommended dosage is 2-4 teaspoonfuls (5 mL) every 4 hours. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Akin Expectorant Formula Strawberry Banana, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.