Product Details

CROMOLYN SODIUM 100 MG AMP 96X5 ML

Manufacturer: WOODWARD LABS

MFG#: 69784-0200-96

NDC: 69784-0200-96

PID: 228382

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Product Properties:

Description -
Description N
Description N
DESI Drug Ind $0.80; 04/01/2017
DESI Drug Ind -
DESI Drug Ind $0.80; 04/01/2017
DESI2 Drug Ind AA
Drug Category USES: This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (such as histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.
Drug Category NJ
Drug Category USES: This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (such as histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.
Drug Type Code COMMON BRAND NAME(S): Gastrocrom
Drug Type Code COMMON BRAND NAME(S): Gastrocrom
Drug Type Code N
FDA Approval Date 01/17/2018
FDA Therap Equiv ML
HCPCS -
HCPCS 1
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (CROW-mow-lin)
Termination Date 1
Termination Date (CROW-mow-lin)
Unit 5
Units Per Pkg 10/16/2017
Active Ingredients 3422 cromolyn sodium 15826376
Active Ingredients 3422 cromolyn sodium 15826376
Active Ingredients 3422 cromolyn sodium 15826376
AHFS Class 48103200 MAST-CELL STABILIZERS
AHFS Class 48103200 MAST-CELL STABILIZERS
AHFS Class 48103200 MAST-CELL STABILIZERS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form CONCENTRATE, ORAL
Dose Form CONCENTRATE, ORAL
Dose Form CONCENTRATE, ORAL
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 25061 cromolyn sodium ORAL ORAL CONC 20 MG/ML
Gen Code and Des 25061 cromolyn sodium ORAL ORAL CONC 20 MG/ML
Gen Code and Des 25061 cromolyn sodium ORAL ORAL CONC 20 MG/ML
Inactive Ingredients -
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 100MG
Strength 100MG
Strength 100MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Gastrocrom
Common Brand Name -
Drug Interaction -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 6
Case Quantity 6
Case Quantity 6
Drug Form Pack Size 480
Drug Form Pack Size 480
Drug Form Pack Size 480
Form AMPULE
Form AMPULE
Form AMPULE
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 96X5
Unit Size 96X5
Unit Size 96X5
How to Use -
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or as directed by your doctor. If you are using this drug to prevent a food allergy or for inflammatory bowel disease, your doctor may direct you to take it 15-20 minutes before meals. Do not swallow the ampules. The contents of the ampules are used to make a solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. To make the solution, break open the ampule(s) and squeeze the liquid into a glass of water. Do not mix with fruit juice, soda, milk, or any fluid except plain water. Stir the solution well. Drink all of the solution right away. Do not mix it ahead of time. Do not take the ampules out of their foil pouch until right before using. Dosage is based on your medical condition and response to therapy. This medication does not work right away. You need to use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take 2-3 weeks before you see a benefit from this medication. Your doctor may change your dose to find the best dose for you. Do not use this form of cromolyn for inhalation (such as in a nebulizer), in the nose, or by injection. It is for oral use (swallowing) only. It does not work to treat breathing problems, nasal/seasonal allergies, or other allergic reactions. Inform your doctor if your symptoms do not improve or if they worsen.
Missed Dose 5
Missed Dose 5
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If you have already had your meal, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes ML
Notes ML
Notes NOTES: Do not share this medication with others.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose AA
Overdose AA
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (CROW-mow-lin)
Precautions PRECAUTIONS: Before taking cromolyn, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions -
Precautions -
Side Effects -
Side Effects -
Side Effects SIDE EFFECTS: Headache, muscle aches, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage 10/16/2017
Storage 10/16/2017
Storage STORAGE: Keep the ampules in their foil pouches at room temperature away from heat and light until ready for use. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses -
Uses -
Uses USES: This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (such as histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

Frequently Asked Questions (FAQs)

The cost of CROMOLYN SODIUM 100 MG AMP 96X5 ML is $available for registerd members only

CROMOLYN SODIUM 100 MG AMP 96X5 ML is manufactured by WOODWARD LABS.

You can purchase CROMOLYN SODIUM 100 MG AMP 96X5 ML on our website at https://supplies.pipelinemedical.com/product/detail/cromolyn-sodium-100-mg-amp-96x5-ml-228382