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Giltuss Cough and Cold

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Active ingredients
  • Guaifenesin 388 mg
  • Dextromethorphan Hydrobromide 28 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 388 mg
  • Dextromethorphan Hydrobromide 28 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet
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 2021
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-331
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 ® is a medication designed to help relieve symptoms associated with coughs, colds, hay fever, and other upper respiratory allergies. It works by temporarily alleviating issues such as chest congestion, nasal congestion, and sinus pressure. Giltuss ® helps to loosen phlegm (mucus) and bronchial secretions, making coughs more productive and clearing stuffy noses and nasal passageways.

This product is sugar-free, dye-free, and preservative-free, making it a suitable option for those looking for a gentle relief from cold and allergy symptoms. With its ability to shrink swollen membranes and drain bronchial tubes, Giltuss ® aims to provide you with comfort during your recovery.

Uses

If you're dealing with a cough, the common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief from your symptoms. It works by loosening phlegm (mucus) and thinning bronchial secretions, making your coughs more productive.

Additionally, it helps clear nasal passageways and reduces nasal congestion by shrinking swollen membranes. This means you can breathe easier and feel more comfortable when you're under the weather.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 6 to 8 hours as needed. However, make sure not to exceed 4 tablets in a 24-hour period to avoid any potential side effects.

For children between the ages of 6 and 12, the recommended dosage is 1/2 tablet every 6 to 8 hours, with a maximum of 2 tablets in a 24-hour period. If your child is under 6 years old, it’s important to consult a physician (doctor) before giving them this medication to ensure it’s safe and appropriate for their age. Always follow these guidelines to use the medication safely and effectively.

What to Avoid

It's important to use this medication safely. You should never exceed the recommended dosage, as doing so can lead to serious health issues. Additionally, do not use this medication if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) for conditions like depression or Parkinson’s Disease, or for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult a healthcare professional.

Always keep this medication out of the reach of children to prevent accidental ingestion. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

You should be aware of some potential side effects when using this medication. If you experience nervousness, dizziness, or sleeplessness, it's important to stop using the product and consult a doctor. Additionally, if you have symptoms like fever, rash, persistent headache, or excessive mucus, or if your cough and congestion do not improve within 7 days or keep coming back, these could indicate a more serious condition.

Before using this medication, consult your doctor if you have any of the following: heart disease, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Also, do not exceed the recommended dosage or use this medication if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have taken one in the past two weeks, as this could lead to serious interactions.

Warnings and Precautions

It's important to follow the recommended dosage and avoid using this medication if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have stopped taking one within the last two weeks. MAOIs are specific medications used for depression and other conditions, so if you're unsure whether your medication is an MAOI, please consult a healthcare professional.

Before using this medication, talk to your doctor if you have any of the following conditions: heart disease, excessive mucus, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate, or a chronic cough from smoking or respiratory issues. If you experience nervousness, dizziness, sleeplessness, fever, rash, persistent headache, or if your cough and congestion do not improve within seven days, stop using the medication and contact your doctor, as these may indicate a more serious issue.

In the event of an accidental overdose, seek emergency medical help or contact a Poison Control Center right away. Your safety is the top priority, so please take these precautions seriously.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help right away or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you’re unsure whether you or someone else has taken too much of a 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 your child is between 6 to 12 years old, they can take half a tablet every 6 to 8 hours, but it's important not to exceed 2 tablets in a 24-hour period. For children under 6 years of age, you should consult a physician (doctor) before giving them this medication. Always ensure you follow these guidelines to keep your child safe and healthy.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team 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 change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's crucial to talk to your healthcare provider about any medications you are currently taking. Specifically, if you are on a prescription Monoamine Oxidase Inhibitor (MAOI), you should not use this medication while taking the MAOI or for at least two weeks after stopping it. This is important because combining these drugs can lead to serious interactions that may affect your health.

Always keep your healthcare provider informed about all the medications and supplements you are using. This helps ensure your treatment is safe and effective, minimizing the risk of any harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, following the standards set by the United States Pharmacopeia (USP). It's important to check the packaging before use; do not use the product if the blister seal is broken, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure your safety during use.

Additional Information

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 6 to 8 hours, with a maximum of 4 tablets in a 24-hour period. For children aged 6 to 12 years, the dosage is 1/2 tablet every 6 to 8 hours, not exceeding 2 tablets in a 24-hour period. If your child is under 6 years old, you should consult a physician for guidance on appropriate dosing.

FAQ

What is Giltuss ® used for?

Giltuss ® is used to temporarily relieve symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies.

How does Giltuss ® work?

It helps loosen phlegm (mucus), clears nasal passageways, drains bronchial tubes, and makes coughs more productive.

What are the dosage instructions for adults?

Adults and children 12 years and over should take 1 tablet every 6 to 8 hours, not exceeding 4 tablets in a 24-hour period.

What are the dosage instructions for children?

Children 6 to 12 years of age should take 1/2 tablet every 6 to 8 hours, not exceeding 2 tablets in a 24-hour period. Consult a physician for children under 6 years.

Are there any contraindications for Giltuss ®?

Do not use more than the recommended dosage or if you are taking a prescription Monoamine Oxidase Inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience nervousness, dizziness, sleeplessness, or if symptoms are accompanied by fever, rash, or excessive phlegm.

Is Giltuss ® safe during pregnancy or breastfeeding?

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

How should Giltuss ® be stored?

Store Giltuss ® at room temperature and do not use if the blister seal is broken.

Packaging Info

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

Packaging configurations for Giltuss Cough and Cold.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Cough and Cold, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with cough, the common cold, hay fever, and other upper respiratory allergies. It aids in loosening phlegm (mucus) and thins bronchial secretions, thereby facilitating drainage of the bronchial tubes and making coughs more productive. Additionally, it helps to clear nasal passageways and relieve nasal congestion by shrinking swollen membranes.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 tablet every 6 to 8 hours as needed. The maximum allowable dosage is 4 tablets within a 24-hour period.

For children aged 6 to 12 years, the recommended dosage is 1/2 tablet every 6 to 8 hours. The total daily limit for this age group is 2 tablets within a 24-hour period.

In the case of children under 6 years of age, it is essential to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

The recommended dosage should not be exceeded.

This product should not be used concurrently with prescription Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s Disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, this product must be kept out of the reach of children.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage, as exceeding this may lead to adverse effects. The concurrent use of this medication with prescription Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s Disease. Patients must refrain from using this medication while on MAOIs and for at least two weeks following the cessation of such treatment. If there is any uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Healthcare professionals should exercise caution and recommend that patients consult a physician prior to use if they have any of the following conditions: heart disease, excessive phlegm (mucus), high blood pressure, diabetes, thyroid disease, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), or if cough and congestion do not improve within seven days or tend to recur, medical consultation is necessary, as these may indicate a serious underlying condition.

In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure prompt and appropriate care.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur, particularly if they are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), as these could indicate a serious condition.

Common adverse reactions may include cough and congestion that do not improve within 7 days or tend to recur. Patients are advised to seek medical advice if such symptoms persist.

Before using this medication, patients should consult a healthcare provider if they have a history of heart disease, excessive phlegm (mucus), high blood pressure, diabetes, thyroid disease, difficulty in urination due to prostate gland enlargement, or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients are cautioned against exceeding the recommended dosage and should not use this medication if they are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have taken one within the past two weeks. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should seek clarification from a healthcare professional.

Drug Interactions

The concomitant use of this medication with prescription Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy, as this may result in serious interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

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

Packaging configurations for Giltuss Cough and Cold.
Details

Pediatric Use

Pediatric patients aged 6 to 12 years may take 1/2 tablet every 6 to 8 hours, with a maximum of 2 tablets in a 24-hour period. For children under 6 years of age, consultation with a physician is advised prior to use.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health 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 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 event of an accidental overdose, it is imperative to seek medical assistance without delay. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center immediately for guidance on appropriate actions to take.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and implement necessary measures based on the clinical presentation. It is crucial to follow established protocols for overdose management, which may include decontamination, administration of antidotes if applicable, and supportive therapies as needed.

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

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

Patients must be cautioned against exceeding the recommended dosage of the medication. It is essential to inform patients that they should not use this medication if they are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have stopped taking an MAOI drug within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult a healthcare professional for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to seek medical advice if these symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm, or if cough and congestion do not improve within seven days or tend to recur, as these may indicate a serious condition.

Before initiating treatment, healthcare providers should recommend that patients consult a doctor if they have any of the following conditions: heart disease, excessive phlegm, high blood pressure, diabetes, thyroid disease, difficulty urinating due to prostate gland enlargement, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes NDC numbers, which are essential for identification. It is important to store the product at room temperature, in accordance with USP guidelines. Care should be taken to ensure that the blister seal remains intact; the product should not be used if the blister seal is broken. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 6 to 8 hours, with a maximum of 4 tablets in a 24-hour period. For children aged 6 to 12 years, the recommended dosage is 1/2 tablet every 6 to 8 hours, not exceeding 2 tablets in a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to administration.

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 Giltuss Cough and Cold, 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 Cough and Cold, 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.