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Giltuss Diabetic Dm

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Active ingredient
Dextromethorphan Hydrobromide 30 mg/10 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
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
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/10 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
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
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-149
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

Giltuss Diabetic DM is a medication designed to help manage symptoms associated with coughs, particularly those that may occur in individuals with diabetes. It is formulated to provide relief from coughs that may be accompanied by phlegm (mucus). This product is available in both bottle and carton packaging, making it easy to identify and use.

If you are considering using Giltuss Diabetic DM, it is important to consult with a healthcare professional, especially if you have a cough that produces a lot of mucus or if you have a chronic cough due to conditions like smoking or asthma.

Uses

If you're dealing with a cough, it's important to know when to seek medical advice. You should consult a doctor before using this medication if your cough produces a lot of phlegm (mucus) or if you have a persistent cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema.

Additionally, if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, you should stop using the medication and talk to your doctor. These symptoms could indicate a more serious health issue that needs attention.

Dosage and Administration

It's important to follow the recommended dosage when taking this medication to ensure your safety and effectiveness. For adults and children over 12 years old, you should take 10 milliliters (mL) every 8 hours. If you're giving this medication to children between the ages of 6 and 12, the dose is 5 mL every 8 hours. For younger children aged 4 to under 6 years, the appropriate dose is 2.5 mL every 8 hours, and you should use a measuring syringe or cup to ensure accuracy.

Make sure not to exceed 4 doses within a 24-hour period, and always use the enclosed dosing cup for measuring. If your child is under 4 years old, this medication is not recommended for them. Remember, sticking to these guidelines is crucial for safe use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular conditions or situations where you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that this medication can cause some side effects. It's important to avoid using it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain emotional conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

Additionally, always follow the recommended dosage and do not exceed the directed amount while using this medication. If you experience any unusual symptoms or reactions, contact your healthcare provider for guidance.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.

It's important to follow the dosage instructions carefully and not exceed the recommended amount. If you experience any unusual symptoms or have concerns while using this product, stop taking it and contact your doctor for further guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it’s better to be safe and get help if you have any concerns.

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

It’s important to be cautious when giving this medication to children. For children under 4 years old, you should not use this medication at all. If your child is between 4 and 6 years old, the recommended dose is 2.5 mL every 8 hours. For children under 12 years, the dose increases to 5 mL every 8 hours.

For those aged 12 and older, the dosage is 10 mL every 8 hours. Always make sure to use an appropriate measuring syringe or cup to ensure accurate dosing.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when taking dextromethorphan HBr, especially if you are also using monoamine oxidase inhibitors (MAOIs), which are a type of medication used to treat certain mental health conditions. Using dextromethorphan HBr while on MAOIs can lead to serious interactions, so you should avoid taking it during MAOI therapy and for at least two weeks after stopping the MAOI.

Always discuss any medications you are taking, including over-the-counter drugs like dextromethorphan HBr, with your healthcare provider. This ensures that you can safely manage your health and avoid any potential risks.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). It's important to keep the cap tightly closed to maintain its integrity. Additionally, remember to save the carton, as it contains important information about the drug, including complete facts that you may need later.

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

Additional Information

No further information is available.

FAQ

What is Giltuss Diabetic DM?

Giltuss Diabetic DM is a medication presented on both a bottle label and a carton label.

What should I ask my doctor before using Giltuss Diabetic DM?

You should ask your doctor if you have a cough with too much phlegm (mucus) or a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema.

When should I stop using Giltuss Diabetic DM?

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

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

The recommended dosage is 10 mL every 8 hours.

What is the dosage for children under 12 years?

Children under 12 years should take 5 mL every 8 hours, while children 4 to under 6 years should take 2.5 mL every 8 hours.

Are there any contraindications for Giltuss Diabetic DM?

There are no contraindications listed for Giltuss Diabetic DM.

Can I use Giltuss Diabetic DM if I am taking an MAOI?

No, do not use Giltuss Diabetic DM if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping it.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Giltuss Diabetic DM.

How should I store Giltuss Diabetic DM?

Store Giltuss Diabetic DM at room temperature between 15°-30°C (59°-86°F) and close the cap tightly.

Packaging Info

Below are the non-prescription pack sizes of Giltuss Diabetic Dm (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Diabetic Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough. It is essential for healthcare professionals to advise patients to consult a doctor prior to use if they have a cough accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

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

Dosage and Administration

Healthcare professionals are advised to adhere to the following dosage and administration guidelines. It is imperative not to exceed the recommended dosage and to limit administration to a maximum of four doses within any 24-hour period. The enclosed dosing cup should be utilized for accurate measurement, with 1 mL equivalent to one milliliter.

For adults and children over 12 years of age, the recommended dosage is 10 mL administered every 8 hours. For children aged 6 years to under 12 years, the dosage is 5 mL every 8 hours. For children aged 4 years to under 6 years, a dosage of 2.5 mL every 8 hours is appropriate, and it is essential to use an appropriate measuring syringe or measuring cup for this age group.

Administration is not recommended for children under 4 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, the use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s prescription includes an MAOI by consulting with the patient or reviewing their medication history.

It is imperative that patients adhere strictly to the recommended dosage. Exceeding the directed amount may lead to adverse effects and compromise patient safety.

Healthcare providers should remain vigilant in monitoring patients for any potential interactions or side effects associated with the use of this product, particularly in those with a history of MAOI use.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is crucial for patients to consult with a healthcare professional if they are uncertain whether their prescription includes an MAOI before using this product.

In addition to the serious warnings regarding MAOI interactions, patients are advised to adhere strictly to the recommended dosage. Exceeding the directed use may lead to adverse effects, although specific common side effects have not been detailed in the available data.

Overall, careful consideration and consultation with healthcare providers are essential to mitigate the risks associated with the use of this product.

Drug Interactions

Dextromethorphan HBr is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) due to the potential for serious interactions. It is advised to avoid the use of dextromethorphan HBr during MAOI therapy and for a period of 2 weeks following the discontinuation of the MAOI to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been identified for dextromethorphan HBr.

Packaging & NDC

Below are the non-prescription pack sizes of Giltuss Diabetic Dm (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Diabetic Dm.
Details

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 years to under 6 years, the recommended dosage is 2.5 mL every 8 hours. In children under 12 years, the dosage increases to 5 mL every 8 hours. For adolescents and adults over 12 years, the dosage is 10 mL every 8 hours. It is essential to use an appropriate measuring syringe or measuring cup to ensure accurate dosing.

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. It is advisable to monitor these patients closely for any 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 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 have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and be prepared to respond to potential overdose situations with appropriate medical interventions.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. It is essential to store the product in a location that is inaccessible to children to prevent accidental ingestion or misuse. Emphasizing the importance of proper storage can help ensure the safety of pediatric patients.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). To ensure the integrity of the product, the carton should be retained for reference to the complete drug facts.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Giltuss Diabetic Dm, 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 Giltuss Diabetic Dm, 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

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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.