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Giltuss Severe Sinus

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
Route
Nasal
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 2020
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-142
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 fast-acting nasal spray designed to provide temporary relief from nasal congestion caused by conditions such as the common cold, hay fever, and upper respiratory allergies. It works by shrinking swollen nasal membranes, allowing you to breathe more freely and alleviating sinus congestion and pressure.

This extra moisturizing pump mist offers relief that can last up to 12 hours, helping to clear a stuffy nose and improve your comfort throughout the day.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or upper respiratory allergies, this medication can help provide temporary relief. It works by shrinking swollen nasal membranes, allowing you to breathe more freely. Additionally, it can alleviate sinus congestion and pressure, making it easier for you to feel comfortable.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To open it, align the marks on the cap and squeeze the sides while turning it counter-clockwise to remove it. When you're ready to spray, hold the bottle with your thumb at the base and your fingers around the nozzle. Keep your head upright, insert the nozzle into your nostril, and press down firmly while sniffing deeply to ensure the medication goes in properly. After using, wipe the nozzle clean and securely snap the cap back on.

For adults and children aged 6 to under 12 years, you can use 2 or 3 sprays in each nostril, but remember not to do this more than every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. If you're considering this medication for a child under 6 years old, please consult a doctor first.

What to Avoid

It's important to use this medication responsibly to avoid potential issues. You should not use it for more than three days, as prolonged use can lead to worsening nasal congestion. Always follow the directions provided and do not exceed the recommended dosage. By adhering to these guidelines, you can help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, you may experience temporary discomfort, which can include sensations like burning, stinging, sneezing, or an increase in nasal discharge. These side effects are generally mild and should not last long.

However, if your symptoms persist, it’s important to stop using the product and consult a doctor for further advice.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland. Always follow the directions carefully—do not exceed the recommended dosage or use it for more than three days. Overuse can lead to worsening nasal congestion, and you may experience temporary discomfort like burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. If your symptoms do not improve, stop using the product and reach out to your doctor for further advice.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, do not hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

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

When using this medication for children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but make sure to do this only every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. For children under 6 years of age, you should consult a doctor before use to ensure safety and proper guidance. Always supervise your child during administration to ensure they are using the medication correctly.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains valuable information and labeling that you may need for future reference.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication through the nasal route. For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril. Make sure to wait at least 10 to 12 hours between doses, and do not exceed 2 doses within a 24-hour period.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Giltuss®?

Giltuss® is a fast and powerful nasal spray that provides extra moisturizing relief for nasal congestion.

What conditions does Giltuss® relieve?

Giltuss® temporarily relieves nasal congestion due to the common cold, hay fever, upper respiratory allergies, and sinus congestion and pressure.

How long does Giltuss® provide relief?

You can expect up to 12 hours of relief from nasal congestion and stuffy nose with Giltuss®.

What are the administration instructions for Giltuss®?

Shake well before use, align the cap marks to open, and spray 2 or 3 sprays in each nostril without tilting your head.

What is the recommended dosage for children aged 6 to under 12?

Children aged 6 to under 12 years should use 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and should not exceed 2 doses in any 24-hour period.

What should I do if symptoms persist?

Stop using Giltuss® and ask a doctor if your symptoms persist.

Are there any side effects associated with Giltuss®?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur when using Giltuss®.

Can I use Giltuss® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Giltuss®.

What precautions should I take when using Giltuss®?

Do not use more than directed or for more than 3 days, as frequent or prolonged use may worsen nasal congestion.

What should I do if Giltuss® is swallowed?

Keep Giltuss® out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

Packaging Info

Below are the non-prescription pack sizes of Giltuss Severe Sinus (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Severe Sinus.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Severe Sinus, 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 nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It also provides temporary relief from sinus congestion and pressure by shrinking swollen nasal membranes, facilitating easier breathing.

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

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, should receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

Prior to administration, the bottle must be shaken well. To open the bottle, the cap should be rotated to align the marks, and then squeezed on both sides in a counter-clockwise direction to remove it. For proper administration, the bottle should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. A firm, even stroke should be used to fully depress the nozzle while the patient sniffs deeply. After use, the nozzle should be wiped clean, and the cap should be snapped back onto the bottle to ensure proper closure.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a physician prior to use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

When administering this product, it is crucial to adhere to the recommended dosage. Patients should not exceed the directed use and should limit the duration of use to no more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this container with others may facilitate the spread of infection.

In the event of accidental ingestion, the product should be kept out of reach of children. Immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Patients should discontinue use and consult a healthcare provider if symptoms persist.

Side Effects

Patients using this product may experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Giltuss Severe Sinus (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Severe Sinus.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered with adult supervision. Dosing should not occur more frequently than every 10 to 12 hours, and the total daily dosage must not exceed 2 doses within a 24-hour period.

For children under 6 years of age, it is advised to consult a doctor before administration.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 text 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions, including nasal congestion, burning, stinging, sneezing, and increased nasal discharge. Additionally, there have been instances of infection spread associated with the use of this container by more than one person.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to emphasize that patients should not exceed the directed dosage and should not use it for more than three days. Frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It is also important to inform patients that sharing this container with others may spread infection.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for future reference on full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

Additional Clinical Information

The route of administration for the medication is nasal. For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours, and should not exceed 2 doses within a 24-hour period.

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

Drug Information (PDF)

This file contains official product information for Giltuss Severe Sinus, 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 Severe Sinus, 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.

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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.