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Cromolyn sodium
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- Active ingredient
- Cromolyn Sodium 5.2 mg/1 mL – 5.2 mg
- Drug class
- Mast Cell Stabilizer
- Dosage form
- Spray, Metered
- Route
- Nasal
- Prescription status
- OTC (over the counter)
- Marketed in the U.S.
- Since 2001
- Label revision date
- October 30, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Active ingredient
- Cromolyn Sodium 5.2 mg/1 mL – 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
- Marketed in the U.S.
- Since 2001
- Label revision date
- October 30, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
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Drug Overview
Cromolyn Sodium is a nasal spray used to prevent and relieve symptoms associated with hay fever and other nasal allergies. It works by controlling nasal allergy symptoms such as a runny or itchy nose, sneezing, and an allergic stuffy nose. Each spray delivers 5.2 mg of cromolyn sodium and is safe for use in individuals aged 2 years and older.
This medication is available in metered spray form, with options for 100 or 200 sprays per package. It is designed for intranasal use only and does not cause drowsiness, making it a suitable choice for managing allergy symptoms throughout the day.
Uses
Cromolyn Sodium is used 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 medication can provide relief.
It is important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication.
Dosage and Administration
To use Cromolyn Sodium nasal spray, adults and children aged 2 years and older should spray once into each nostril. You can repeat this 3 to 4 times a day, every 4 to 6 hours, and if necessary, you may use it up to 6 times a day. It's important to use the spray every day while you are in contact with allergy triggers such as pollen, molds, pets, and dust. For the best results in preventing nasal allergy symptoms, start using the spray up to one week before you expect to come into contact with these allergens.
If you are using this product with other allergy medications, that is acceptable. However, do not use Cromolyn Sodium nasal spray in children under 2 years of age unless directed by a doctor.
What to Avoid
You should avoid using Cromolyn Sodium if you are allergic to any of its ingredients. Additionally, do not use this product to treat sinus infections, asthma, or cold symptoms. It's important to refrain from sharing the bottle with others, as this can spread germs.
Side Effects
You should be aware of some potential side effects when using Cromolyn Sodium (also known as Nasalcrom) nasal spray. Common reactions may include brief stinging or sneezing right after use. More serious reactions can occur, such as shortness of breath, wheezing, chest tightness, hives, or swelling of the mouth or throat. If you experience any of these symptoms, or if your condition worsens or does not improve within two weeks, you should stop using the product and consult a doctor.
Do not use this product if you are allergic to any of its ingredients. It's also important to ask a doctor before use if you have fever, discolored nasal discharge, sinus pain, or wheezing. If you are pregnant or breastfeeding, consult a health professional before using it. Keep the spray out of reach of children, and seek medical help immediately if swallowed.
Warnings and Precautions
For external use only. Do not use this product if you are allergic to any of its ingredients. Before using, consult your doctor if you have a fever, discolored nasal discharge, sinus pain, or wheezing.
Stop using and call your doctor if you experience shortness of breath, wheezing, or chest tightness; hives or swelling of the mouth or throat; worsening symptoms; new symptoms; or if your symptoms do not improve within two weeks. Additionally, do not use for more than 12 weeks without consulting a doctor. If you are pregnant or breastfeeding, seek advice from a health professional before use.
If swallowed, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Overdose
If you accidentally swallow Cromolyn Sodium or Nasalcrom, it's important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. While there is no specific information about the effects of an overdose, it's always better to be cautious. Signs of an overdose can vary, so if you experience any unusual symptoms, don't hesitate to get help.
Pregnancy Use
If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using Cromolyn Sodium or Nasalcrom. These medications are available in a metered spray form and may have specific considerations for your health during this time. Always prioritize your well-being and that of your baby by seeking professional advice.
Lactation Use
If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using Nasalcrom. This ensures that any potential effects on you or your baby are carefully considered. Always prioritize your health and your baby's well-being when making decisions about medication during this time.
Pediatric Use
You can use Nasalcrom nasal spray for children aged 2 years and older. The recommended dosage is to spray once into each nostril 3 to 4 times a day, with a maximum of 6 times if needed. It's important that a parent or caregiver supervises its use in young children. For children under 2 years old, do not use this product unless directed by a doctor.
Geriatric Use
When using Nasalcrom, a nasal spray, there are no specific guidelines or dosage adjustments provided for older adults. This means that while the product may be safe for use, it is important to consult with your healthcare provider before starting treatment, especially if you have any underlying health conditions or are taking other medications. Always follow the instructions on the label and report any unusual side effects to your doctor.
Renal Impairment
When using Cromolyn Sodium or Nasalcrom (both available as a metered spray), you can feel reassured that there are no specific dosage adjustments or monitoring requirements related to kidney problems mentioned in the product information. This means that, based on the available data, these medications do not require special considerations for individuals with renal impairment. However, it's always a good idea to consult with your healthcare provider if you have any concerns about your kidney health or how it may affect your medication.
Hepatic Impairment
You can use Cromolyn Sodium and Nasalcrom sprays without specific concerns regarding liver issues, as there is no information provided about dosage adjustments, special monitoring, or precautions for individuals with liver problems. This means that if you have liver impairment, you can use these medications as directed without needing to make any changes to your usual dosage or monitoring practices. Always consult your healthcare provider if you have any questions or concerns about your medications.
Drug Interactions
When using Nasalcrom, a nasal spray, there are no known interactions with other medications or laboratory tests. This means that it is generally considered safe to use alongside other treatments. However, it's always important to discuss all medications and tests with your healthcare provider. They can help ensure that your treatment plan is safe and effective, taking into account your unique health needs.
Storage and Handling
To ensure the effectiveness of Nasalcrom, store it at room temperature between 20°-25°C (68°-77°F) and protect it from light. It's important to keep the carton and package insert, as they contain essential instructions. Always check the bottom panel for the lot number and expiration date to ensure the product is still safe to use.
When disposing of Nasalcrom, follow local regulations for medication disposal. If you're unsure, consult your pharmacist for guidance on safe disposal methods.
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.
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.
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 is NasalCrom?
NasalCrom is a cromolyn sodium nasal solution used to prevent and relieve nasal symptoms of hay fever and other nasal allergies.
What should I do if I accidentally swallow NasalCrom?
If swallowed, get medical help or contact a Poison Control Center immediately.
How should I store NasalCrom?
Store NasalCrom between 20°-25°C (68°-77°F) and protect it from light.
Uses and Indications
This drug is indicated for the prevention and relief of nasal symptoms associated with hay fever and other nasal allergies, including runny or itchy nose, sneezing, and allergic stuffy nose.
Limitations of Use No teratogenic or nonteratogenic effects have been mentioned.
Dosage and Administration
Adults and children aged 2 years and older are instructed to spray once into each nostril. This may be repeated 3 to 4 times a day, approximately every 4 to 6 hours. If necessary, the spray may be used up to 6 times a day. It is recommended to use the spray daily while in contact with allergens such as pollen, molds, pets, and dust. For optimal prevention of nasal allergy symptoms, it is advised to use the spray before exposure to allergens, ideally starting up to one week prior to anticipated contact.
Children under 2 years of age should not use this product unless directed by a healthcare professional. The spray can be used in conjunction with other medications, including other allergy treatments, if desired.
Contraindications
Do not use in individuals who are allergic to any of the ingredients. The product is also contraindicated for the treatment of sinus infections, asthma, or cold symptoms. Additionally, sharing this bottle with others is not recommended as it may facilitate the spread of germs.
Warnings and Precautions
For external use only. Do not use if allergic to any of the ingredients.
General Precautions
Before using this product, it is advised to consult a doctor if the individual has any of the following conditions:
Fever
Discolored nasal discharge
Sinus pain
Wheezing
When Using
It may take several days of use to notice an effect, with optimal results typically seen after 1 to 2 weeks.
Brief stinging or sneezing may occur immediately after use.
This product should not be used to treat sinus infections, asthma, or cold symptoms.
Do not share this bottle with anyone else to prevent the spread of germs.
Stop Use and Call Your Doctor If
Shortness of breath, wheezing, or chest tightness occurs.
Hives or swelling of the mouth or throat occurs.
Symptoms worsen or new symptoms develop.
Symptoms do not begin to improve within two weeks.
Use exceeds 12 weeks.
If pregnant or breastfeeding, consult a health professional before use.
Get Emergency Medical Help
If swallowed, seek medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Side Effects
Patients using Cromolyn Sodium (Nasalcrom) may experience several adverse reactions, which can be categorized by seriousness and frequency.
Common Reactions
Brief stinging or sneezing may occur immediately after use.
Serious Reactions
Patients should discontinue use and consult a healthcare professional if any of the following occur:
Shortness of breath, wheezing, or chest tightness.
Hives or swelling of the mouth or throat.
Worsening of symptoms or the emergence of new symptoms.
Symptoms do not begin to improve within two weeks.
The need for use extends beyond 12 weeks.
Warnings
This product is for external use only.
It should not be used by individuals who are allergic to any of its ingredients.
Patients should seek medical advice before use if they have:
Fever
Discolored nasal discharge
Sinus pain
Wheezing
Special Considerations
Pregnant or breastfeeding patients are advised to consult a healthcare professional before use.
The product should be kept out of reach of children, and in case of ingestion, medical help or contact with a Poison Control Center (1-800-222-1222) is recommended.
Drug Interactions
There are no documented drug interactions associated with Nasalcrom, which is available in a metered spray form. Additionally, there is no information regarding interactions with laboratory tests. Therefore, healthcare professionals can consider Nasalcrom as having a low potential for drug interactions in clinical use.
Pediatric Use
Pediatric patients aged 2 years and older may use Nasalcrom as a metered spray, with the recommended dosage being one spray into each nostril 3-4 times a day (every 4-6 hours). If necessary, the spray may be administered up to 6 times a day. For children under 2 years of age, the use of this product is not recommended unless directed by a healthcare provider. It is advised that a parent or caregiver supervise the administration of this product in young children.
Geriatric Use
Elderly patients may use Nasalcrom; however, the labeling does not provide specific information regarding dosage adjustments, safety concerns, or special precautions for this population. Healthcare professionals should consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring for efficacy and tolerability.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using Cromolyn Sodium or Nasalcrom. There is limited data available regarding the safety of these medications during pregnancy and lactation. Therefore, healthcare providers should evaluate the potential benefits against any risks when considering treatment options for pregnant patients.
Lactation
Lactating mothers are advised to consult a healthcare professional before using Nasalcrom, particularly if they are breastfeeding. There is limited data available regarding the excretion of the active ingredients in breast milk and their potential effects on breastfed infants. Therefore, caution is recommended to ensure the safety and well-being of both the mother and the infant during lactation.
Renal Impairment
Patients with renal impairment do not have specific dosage adjustments, monitoring requirements, or safety considerations outlined in the product inserts for Cromolyn Sodium or its formulations, including Nasalcrom. The available data does not provide guidance on the use of these medications in individuals with reduced kidney function. Therefore, healthcare professionals should exercise caution and consider the lack of information when prescribing these treatments to patients with renal impairment.
Hepatic Impairment
Patients with hepatic impairment do not have specific dosage adjustments, special monitoring requirements, or precautions outlined in the drug inserts for Cromolyn Sodium or Nasalcrom. The available information does not indicate any need for alterations in treatment or additional monitoring parameters for this patient population.
Overdosage
In the event of an overdose of Cromolyn Sodium or Nasalcrom, immediate medical assistance should be sought. If the product is swallowed, it is crucial to contact a Poison Control Center at 1-800-222-1222 without delay.
Currently, there is no specific information available regarding the symptoms associated with an overdose of these medications. However, monitoring for any unusual reactions or symptoms is advisable. Healthcare professionals should be prepared to provide supportive care as needed.
Nonclinical Toxicology
Teratogenicity
The use of Nasalcrom during pregnancy or lactation is advised to be approached with caution. It is recommended that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No specific data regarding carcinogenicity, mutagenicity, or impairment of fertility have been provided in the available information. Additionally, there are no documented effects related to non-teratogenicity or specific animal pharmacology and toxicology.
Storage and Handling
Nasalcrom is supplied as a metered spray. It should be stored between 20°-25°C (68°-77°F) and protected from light. It is important to keep the carton and package insert, as they contain essential instructions. Users should also refer to the bottom panel for the lot number and expiration date.
Product Labels
The table below lists all over-the-counter labels containing cromolyn sodium. Use it to compare dosage forms, strengths, and uses across products.
More Details | |||||
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Bausch & Lomb Incorporated | Spray, Metered | Nasal | 5.2 mg | 2001 | |
Indications
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CVS Pharmacy | Spray, Metered | Nasal | 5.2 mg/1 mL | 2001 | |
Indications
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Prestige Brands Holdings, Inc. | Spray, Metered | Nasal | 5.2 mg | 2009 | |
Indications
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