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Cromolyn sodium
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- Active ingredient
- Cromolyn Sodium 5.2 mg
- Drug class
- Mast Cell Stabilizer
- Dosage form
- Spray, Metered
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2001
- Label revision date
- June 1, 2021
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Cromolyn Sodium 5.2 mg
- Drug class
- Mast Cell Stabilizer
- Dosage form
- Spray, Metered
- 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 2001
- Label revision date
- June 1, 2021
- Manufacturer
- Bausch & Lomb Incorporated
- Registration number
- ANDA075702
- NDC root
- 57782-397
- Drug Information (PDF)
- Prescribing information, PDF file
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
HealthGuard is a nasal spray that contains cromolyn sodium, a medication designed to help prevent and relieve nasal symptoms associated with hay fever and other nasal allergies. If you experience a runny or itchy nose, sneezing, or an allergic stuffy nose, this product may provide you with the relief you need.
Each spray delivers 5.2 mg of cromolyn sodium, making it effective for managing allergy symptoms. HealthGuard is safe for use in individuals aged 2 and older, allowing many people to benefit from its soothing effects.
Uses
If you suffer from hay fever or other nasal allergies, this medication can help you find relief. It is designed to prevent and alleviate common nasal symptoms such as a runny or itchy nose, sneezing, and a stuffy nose caused by allergies.
You can rely on this treatment to make your daily life more comfortable during allergy season, allowing you to breathe easier and enjoy your activities without the bothersome effects of nasal allergies.
Dosage and Administration
If you or your child is 2 years old or older and dealing with allergies, you can use this nasal spray to help relieve symptoms. Simply spray once into each nostril, and you can repeat this 3 to 4 times a day, allowing 4 to 6 hours between doses. If necessary, you can use it up to 6 times a day. It's best to use the spray every day while you're around things that trigger your allergies, like pollen, molds, pets, or dust. For optimal results, start using it up to a week before you expect to come into contact with these allergens.
If you're using this spray to prevent allergy symptoms, make sure to apply it before you encounter the allergens. You can also combine this nasal spray with other allergy medications if you wish. However, if your child is under 2 years old, you should only use this product if a doctor has specifically directed you to do so.
What to Avoid
It's important to be cautious when using this medication. First, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid using this medication to treat sinus infections, asthma, or cold symptoms, as it is not intended for these conditions.
For your safety, never share this medication with anyone else, as doing so can spread germs and increase the risk of infection. Always prioritize your health and consult with a healthcare professional if you have any questions or concerns.
Side Effects
When using this product, you may experience brief stinging or sneezing right after application. It's important to stop using it and consult a doctor if you notice any serious reactions, such as shortness of breath, wheezing, or chest tightness, as well as hives or swelling in your mouth or throat. Additionally, if your symptoms worsen, you develop new symptoms, or if you do not see improvement within two weeks, you should seek medical advice. Prolonged use beyond 12 weeks is also not recommended.
Before using this product, talk to your doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing. Remember, this product is for external use only, and you should avoid it if you are allergic to any of its ingredients.
Warnings and Precautions
This product is for external use only, so please do not apply it to your mouth or swallow it. If you are allergic to any of the ingredients, you should not use this product. Before using it, consult your doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing.
You should stop using the product and contact your doctor if you experience shortness of breath, wheezing, or tightness in your chest. Additionally, seek medical advice if you develop hives or swelling in your mouth or throat, if your symptoms worsen, if you notice new symptoms, if your condition does not improve within two weeks, or if you need to use the product for more than 12 weeks. If the product is swallowed, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.
Overdose
If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.
Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.
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
This product is safe for children aged 2 years and older. If your child is under 2 years old, you should only use it if a doctor specifically advises you to do so. It's important that you supervise your child while they use this product to ensure their safety.
For children aged 2 and older, the recommended dosage is to spray once into each nostril. This can be repeated 3 to 4 times a day, every 4 to 6 hours, and may be used up to 6 times a day if necessary. Always follow these guidelines to ensure your child's well-being.
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 considering this medication, it’s important to consult with a healthcare provider. 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments 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 (issues with liver function).
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 talk to your healthcare provider about any medications you are taking, including allergy medicines. Fortunately, this product is safe to use alongside other medicines, so you can feel confident in managing your allergies without worrying about harmful interactions.
Always keep your healthcare provider informed about all the medications and treatments you are using. This way, they can help ensure that everything works well together for your health and safety.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep the product protected from light, as exposure can affect its effectiveness. Be sure to retain the carton and package insert, as they contain essential instructions for safe use and handling.
When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that you use the product safely and effectively.
Additional Information
You should use this medication as a nasal spray, applying it once into each nostril. You can repeat this 3-4 times a day, every 4-6 hours, and if necessary, up to 6 times a day. For the best results, especially if you know you'll be around allergens like pollen, molds, pets, or dust, start using it up to a week before exposure.
If you are pregnant or breastfeeding, consult a healthcare professional before using this product. It's important that a parent or caregiver supervises its use in young children, and you should keep it out of their reach. If the spray is swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.
FAQ
What is HealthGuard?
HealthGuard is a Cromolyn Sodium Nasal Solution, USP, formulated as a nasal spray.
What symptoms does HealthGuard treat?
HealthGuard prevents and relieves nasal symptoms of hay fever and other nasal allergies, including runny/itchy nose, sneezing, and allergic stuffy nose.
Who can use HealthGuard?
HealthGuard is safe for adults and children aged 2 years and older. Children under 2 years should not use it unless directed by a doctor.
How should I use HealthGuard?
For adults and children 2 years and older, spray once into each nostril 3-4 times a day, and it may be used up to 6 times a day if needed.
Are there any side effects of using HealthGuard?
Some users may experience brief stinging or sneezing right after use. If you experience shortness of breath, wheezing, or swelling, stop use and consult a doctor.
Can I use HealthGuard with other medications?
Yes, you can use HealthGuard with other medicines, including other allergy medications.
What should I do if I accidentally swallow HealthGuard?
If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.
What precautions should I take when using HealthGuard?
Do not use HealthGuard if you are allergic to any of its ingredients, and do not share the bottle with others to prevent spreading germs.
What should I do if my symptoms do not improve?
If your symptoms do not begin to improve within two weeks or worsen, consult a doctor.
How should I store HealthGuard?
Store HealthGuard between 20-25°C (68-77°F) and protect it from light.
Packaging Info
Below are the non-prescription pack sizes of Cromolyn Sodium. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Cromolyn Sodium, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
HealthGuard (NDC 57782-397-26) is a cromolyn sodium nasal solution, USP, formulated as a nasal spray for intranasal use only. This product serves as a nasal allergy symptom controller, designed to prevent and relieve symptoms associated with nasal allergies, including runny or itchy nose, sneezing, and allergic stuffy nose. It is available in original prescription strength and is safe for use in individuals aged 2 years and older. Each 0.88 FL OZ (26 mL) bottle contains 200 metered sprays, with each spray delivering 5.2 mg of cromolyn sodium.
Uses and Indications
This drug is indicated for the prevention and relief of nasal symptoms associated with hay fever and other nasal allergies. Specifically, it addresses symptoms such as runny nose, itchy nose, sneezing, and allergic nasal congestion.
There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.
Dosage and Administration
Adults and children aged 2 years and older are instructed to administer one spray into each nostril. This may be repeated 3 to 4 times daily, with doses spaced every 4 to 6 hours. If necessary, the product may be used up to 6 times a day. For optimal management of nasal allergy symptoms, it is recommended to use the spray daily while in contact with allergens such as pollen, molds, pets, and dust. To prevent the onset of nasal allergy symptoms, administration should occur prior to exposure to allergens, with the best results achieved by starting the regimen up to one week before anticipated contact.
Children under 2 years of age should not use this product unless directed by a healthcare professional. The product may be used concurrently with other medications, including additional allergy treatments, if desired.
Contraindications
Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.
Additionally, the product should not be used for the treatment of sinus infections, asthma, or cold symptoms. It is also contraindicated to share this product with others, as this may facilitate the spread of germs.
Warnings and Precautions
For external use only. This product should not be used by individuals who are allergic to any of its ingredients.
Healthcare professionals are advised to recommend that patients consult a doctor prior to use if they present with any of the following conditions: fever, discolored nasal discharge, sinus pain, or wheezing.
Patients should be instructed to discontinue use and seek medical advice if they experience shortness of breath, wheezing, or chest tightness. Additionally, if hives or swelling of the mouth or throat occurs, or if symptoms worsen, new symptoms arise, or if there is no improvement within two weeks, medical consultation is necessary. Prolonged use beyond 12 weeks should also prompt a discussion with a healthcare provider.
In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.
Side Effects
Patients using this product may experience brief stinging or sneezing immediately following application. It is important to note that this product is for external use only.
Serious adverse reactions may occur, and patients should discontinue use and consult a healthcare professional if they experience shortness of breath, wheezing, or chest tightness. Additionally, the presence of hives or swelling of the mouth or throat warrants immediate medical attention. Patients are advised to stop using the product if their symptoms worsen, if new symptoms develop, or if there is no improvement within two weeks. Prolonged use beyond 12 weeks should also be discussed with a healthcare provider.
Patients with a known allergy to any of the ingredients should not use this product. Furthermore, individuals should seek medical advice before using the product if they have fever, discolored nasal discharge, sinus pain, or wheezing.
Drug Interactions
The product can be safely co-administered with other medications, including those indicated for allergy treatment. No specific dosage adjustments or monitoring requirements are necessary when used in conjunction with these agents.
Packaging & NDC
Below are the non-prescription pack sizes of Cromolyn Sodium. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Spray, Metered | 5.2 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
The product is indicated for pediatric patients aged 2 years and older, demonstrating safety within this age group. For children under 2 years, use is not recommended unless directed by a healthcare professional. It is essential that a parent or caregiver supervises the administration of this product to young children.
For dosing, both adults and children aged 2 years and older should receive one spray into each nostril, with the option to repeat this 3-4 times a day (every 4-6 hours). The product may be used up to a maximum of 6 times a day if necessary.
Geriatric Use
There is no specific information 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.
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 maternal and fetal safety.
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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. 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 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.
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 specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize at this time.
Patient Counseling
Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.
Patients should be informed that it may take several days of consistent use to notice an effect, with optimal results typically observed within 1 to 2 weeks. They should be made aware that brief stinging or sneezing may occur immediately after use, which is a common reaction.
It is important to counsel patients against using this medication for the treatment of sinus infections, asthma, or cold symptoms, as it is not indicated for these conditions. Additionally, patients should be reminded not to share the bottle with anyone else to avoid the spread of germs.
Storage and Handling
The product is supplied in packaging that includes important instructions, which are found in the carton and package insert. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, the product must be protected from light to ensure its stability and integrity.
Additional Clinical Information
For intranasal use only, the product should be administered as a spray once into each nostril, with the option to repeat 3-4 times a day (every 4-6 hours). If necessary, it may be used up to 6 times a day. Patients are advised to use the product daily while in contact with allergens such as pollen, molds, pets, and dust. To effectively prevent nasal allergy symptoms, it is recommended to begin use up to one week prior to exposure to allergens.
Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Additionally, supervision by a parent or caregiver is required for young children using this product. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.
Drug Information (PDF)
This file contains official product information for Cromolyn Sodium, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.