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Cromolyn sodium
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This product has been discontinued
- Active ingredient
- Cromolyn Sodium 5.2 mg/1 mL
- Other brand names
- 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
- December 19, 2011
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Cromolyn Sodium 5.2 mg/1 mL
- Other brand names
- 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
- December 19, 2011
- Manufacturer
- CVS Pharmacy
- Registration number
- ANDA075702
- NDC root
- 59779-075
- 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
Cromolyn sodium nasal solution is a nasal spray designed to help prevent and relieve symptoms associated with nasal allergies, such as hay fever. It works by controlling symptoms like a runny or itchy nose, sneezing, and nasal congestion without causing drowsiness. This medication is suitable for individuals aged 2 years and older and is available in a full prescription strength.
Each spray delivers 5.2 mg of cromolyn sodium, and the bottle contains 200 metered sprays, making it a convenient option for managing allergy symptoms. If you're looking for a way to alleviate your nasal allergy discomfort, cromolyn sodium nasal solution may be a helpful choice.
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 use this medication to manage your symptoms effectively, allowing you to enjoy your daily activities without the discomfort 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 exposed to allergens like pollen, molds, pets, and dust.
For optimal results, consider starting the spray up to a week before you expect to come into contact with allergens. This proactive approach can help prevent allergy symptoms from developing. If you're taking other allergy medications, you can use this spray alongside them, but remember that children under 2 years should only use it if a doctor advises it.
What to Avoid
You should avoid using this medication if you are allergic to any of its ingredients. Additionally, do not use it to treat sinus infections, asthma, or cold symptoms, as it is not intended for these conditions. It's also important to keep this medication to yourself; do not share it with anyone else, as doing so can spread germs.
Side Effects
You should be aware of some potential side effects when using this product. A brief stinging or sneezing may occur right after application. It's important to stop using the product and consult a doctor if you experience shortness of breath, wheezing, or chest tightness, as well as hives or swelling of the 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.
Before using this product, consult a doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing. Also, do not use it if you are allergic to any of its ingredients. If you are pregnant or breastfeeding, please check with a healthcare professional before use.
Warnings and Precautions
You should not use this medication if you are allergic to any of its ingredients. Before starting, it’s important to consult your doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing. Keep in mind that it may take several days to notice any effects, and the best results might not be seen for 1 to 2 weeks. You may experience brief stinging or sneezing after use, and this medication is not intended for treating sinus infections, asthma, or cold symptoms. Remember to avoid sharing the bottle with others to prevent spreading germs.
If you experience shortness of breath, wheezing, chest tightness, hives, or swelling of the mouth or throat, stop using the medication and call your doctor immediately. Additionally, reach out to your doctor if your symptoms worsen, if you develop new symptoms, if you do not see improvement within two weeks, or if you need to use the medication for more than 12 weeks. Pregnant or breastfeeding individuals should consult a healthcare professional before use. If the medication is swallowed, seek emergency medical help or contact a Poison Control Center right away.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention 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
If your child is under 2 years old, it's important not to use this product unless a doctor specifically advises you to do so. For children aged 2 years and older, you can safely use the spray by administering it once into each nostril. This can be repeated 3 to 4 times a day, with a maximum of 6 times if necessary, allowing for 4 to 6 hours between doses.
Always ensure that a parent or caregiver supervises the use of this product in young children to ensure safety and proper usage.
Geriatric Use
When it comes to using this medication, there are no specific guidelines or dosage adjustments noted for older adults. This means that the information available does not highlight any unique safety concerns or recommendations for elderly patients. However, it's always important to consult with your healthcare provider about any medications you or your loved ones are taking, especially if there are other health conditions or medications involved. Your doctor can help ensure that the treatment is safe and effective for your specific needs.
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 (liver issues).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are taking, including cromolyn sodium, which is often used for allergies. While cromolyn sodium can be safely combined with other allergy medications, your doctor can help ensure that all your treatments work well together and are safe for you.
Always keep your healthcare provider informed about all the medicines you use, as they can provide guidance tailored to your specific health needs. This way, you can avoid any potential interactions and get 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°–25°C (68°–77°F). It's important to keep the product protected from light, as exposure can affect its effectiveness. Additionally, make sure to keep 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, administering it once into each nostril. For adults and children aged 2 years and older, you can repeat this 3 to 4 times a day, every 4 to 6 hours, and if necessary, up to 6 times a day.
If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Always supervise young children when they use it, and keep it out of their reach. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately.
FAQ
What is CROMOLYN SODIUM NASAL SOLUTION USP used for?
CROMOLYN SODIUM NASAL SOLUTION USP is a nasal spray used to prevent and relieve nasal allergy symptoms such as runny/itchy nose, sneezing, and allergic stuffy nose.
Who can use this nasal spray?
It 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 CROMOLYN SODIUM NASAL SOLUTION?
You should spray once into each nostril 3-4 times a day (every 4-6 hours), and it may be used up to 6 times a day if needed.
Are there any side effects?
Brief stinging or sneezing may occur right after use. If you experience shortness of breath, wheezing, or swelling of the mouth or throat, stop use and contact a doctor.
Can I use this product with other medications?
Yes, CROMOLYN SODIUM may be used with other medicines, including other allergy medications.
What should I do if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using this product.
What should I avoid while using this nasal spray?
Do not use it to treat sinus infections, asthma, or cold symptoms, and do not share the bottle with others to prevent spreading germs.
How long does it take to notice an effect?
It may take several days to notice an effect, with the best results typically seen after 1 to 2 weeks of use.
What should I do if I accidentally swallow the spray?
If swallowed, seek medical help or contact a Poison Control Center immediately.
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/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not 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
Cromolyn Sodium Nasal Solution USP is a nasal spray formulated as a nasal allergy symptom controller. Each spray delivers 5.2 mg of cromolyn sodium. The product is packaged in a 0.88 fluid ounce (26 mL) container.
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 effectively prevent nasal allergy symptoms, the spray should be used prior to exposure to allergens, with the best results achieved by starting the regimen up to one week before anticipated contact.
In cases where additional relief is desired, this product may be used concurrently with other medications, including other allergy treatments.
For children under 2 years of age, the use of this product is not recommended unless directed by a physician.
Contraindications
Use is contraindicated in individuals with a known allergy to any of the ingredients.
Additionally, the product should not be used for the treatment of sinus infections, asthma, or cold symptoms. It is also advised not to share this product with others to prevent the spread of germs.
Warnings and Precautions
It is imperative that this product not be used by individuals with known allergies to any of its ingredients.
Healthcare professionals should advise patients to consult a physician prior to use if they present with any of the following conditions: fever, discolored nasal discharge, sinus pain, or wheezing.
When utilizing this product, it is important to note that therapeutic effects may not be immediately apparent; patients may require several days of consistent use, with optimal results typically observed within 1 to 2 weeks. Patients may experience brief stinging or sneezing immediately following application. This product is not indicated for the treatment of sinus infections, asthma, or cold symptoms. Additionally, it is crucial to emphasize that this product should not be shared with others to prevent the transmission of germs.
Patients should be instructed to discontinue use and seek medical attention if they experience any of the following: shortness of breath, wheezing, or chest tightness; hives or swelling of the mouth or throat; worsening of symptoms; the emergence of new symptoms; lack of improvement in symptoms within two weeks; or if the product is needed for more than 12 weeks. Pregnant or breastfeeding individuals should consult a healthcare professional before use.
In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.
Side Effects
Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may include allergic reactions, which necessitate immediate discontinuation of use and consultation with a healthcare provider. Symptoms indicative of a serious reaction include shortness of breath, wheezing, chest tightness, hives, or swelling of the mouth or throat. Patients are advised to stop using the product and seek medical advice if any of these symptoms occur.
Commonly reported side effects during use may include brief stinging or sneezing immediately following application. Additionally, patients should consult a healthcare professional prior to use if they are experiencing fever, discolored nasal discharge, sinus pain, or wheezing, as these conditions may warrant caution.
Patients are also advised to discontinue use and consult a doctor if their symptoms worsen, if new symptoms develop, if there is no improvement within two weeks, or if the product is needed for more than 12 weeks.
It is important to note that this product should not be used by individuals with known allergies to any of its ingredients. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.
Drug Interactions
Cromolyn sodium can be co-administered with other medications, including various allergy treatments. There are no known significant pharmacokinetic or pharmacodynamic interactions that would necessitate dosage adjustments or enhanced monitoring when used in conjunction with these agents. However, it is advisable to assess the overall therapeutic regimen to ensure optimal patient outcomes.
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/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 2 years of age should not use this product unless directed by a healthcare professional. For children aged 2 years and older, the recommended dosage is one spray into each nostril, which may be repeated 3 to 4 times a day (every 4 to 6 hours). If necessary, the product may be used up to 6 times a day. It is essential that a parent or care provider supervises the use of this product in young children to ensure safety and proper administration.
Geriatric Use
Elderly patients may not require specific dosage adjustments or safety considerations based on the available data. However, healthcare providers should remain vigilant when prescribing medications to this population, as individual responses may vary. It is advisable to monitor geriatric patients closely for any potential adverse effects or changes in efficacy, given the general physiological changes associated with aging.
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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.
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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.
It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.
Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.
Nonclinical Toxicology
No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.
Postmarketing Experience
Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, swelling of the mouth or throat, shortness of breath, wheezing, and chest tightness.
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 not to use the product if they are allergic to any of its ingredients. They should be advised to stop use and consult a doctor if they experience shortness of breath, wheezing, or chest tightness; hives or swelling of the mouth or throat; worsening symptoms; new symptoms; lack of improvement within two weeks; or if they need to use the product for more than 12 weeks.
For patients who are pregnant or breastfeeding, it is essential to recommend consulting a healthcare professional before use.
When using this product, patients should be made aware that it may take several days to notice an effect, with optimal results potentially not seen for 1 to 2 weeks. They should be informed that brief stinging or sneezing may occur immediately after use. Additionally, patients should be cautioned not to use the product to treat sinus infections, asthma, or cold symptoms, and they should not share the bottle with others to prevent the spread of germs.
Finally, healthcare providers should encourage patients to ask a doctor before use if they have a fever, discolored nasal discharge, sinus pain, or wheezing.
Storage and Handling
The product is supplied in packaging that includes important instructions, which should be retained for reference. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Additionally, the product must be protected from light to ensure its stability and integrity.
Additional Clinical Information
The product is administered nasally, with a recommended dosage for adults and children aged 2 years and older being one spray into each nostril, which may be repeated 3-4 times a day (every 4-6 hours). If necessary, the spray can be used up to 6 times a day.
Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, supervision by a parent or caregiver is required when the product is used by young children. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.
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.