Product Details
SUCRALFATE 1 GM SUS 40X10 ML UD
Manufacturer: PHARMACEUTICAL ASSOC
MFG#: 00121-0974-40
NDC: 00121-0974-40
PID: 236808
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Type Code | 1 |
| FDA Approval Date | 03/15/2022 |
| FDA Therap Equiv | AB |
| HCPCS | - |
| Market Entry Date | 09/15/2022 |
| Medical Coverage | - |
| Termination Date | - |
| Unit | ML |
| Units Per Pkg | 400 |
| Active Ingredients | 1132 sucralfate 54182580 |
| AHFS Class | 56283200 PROTECTANTS |
| DEA Class | NC |
| Dose Form | SUSPENSION, ORAL (FINAL DOSE FORM) |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 16133 sucralfate ORAL ORAL SUSP 1 G/10 ML |
| Inactive Ingredients | 10141 red dye; 1539 ethyl alcohol 64175; 2468 propylene glycol 57556; 2599 sorbitol 50704; 3203 paraben 99967 |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 1GM |
| Common Brand Name | COMMON BRAND NAME(S): Carafate |
| 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. Some products that may interact with this drug include: antacids that contain aluminum, certain antibiotics (including quinolones such as ciprofloxacin/levofloxacin/ofloxacin, tetracyclines), digoxin, ketoconazole, levoketoconazole, penicillamine, phenytoin, quinidine, thyroid medications (such as levothyroxine, liothyronine). |
| Allocation Period | - |
| Case Quantity | 1 |
| Drug Form Pack Size | 400 |
| Form | SUSPENSION |
| Hazard Code | - |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit Size | 40X10 |
| How to Use | HOW TO USE: Shake the bottle well before each dose. Take this medicine by mouth on an empty stomach (at least 1 hour before a meal) as directed by your doctor, usually 4 times daily. The dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. It is important to continue taking this medication even if you do not feel ulcer pain. Do not stop taking this medication without consulting your doctor. It may take 4 to 8 weeks for your ulcer to heal completely. Some medications may not work as well if you take them at the same time as sucralfate. They may need to be taken at a different time of the day than the time you take sucralfate. Ask your doctor or pharmacist for help making a dosing schedule that will work with all your medications. Antacids can be used with this medicine, but they should be taken at least 30 minutes before or after sucralfate. Inform your doctor if your condition lasts or gets worse after you have been taking sucralfate for 4 weeks. |
| Missed Dose | MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. |
| Notes | NOTES: Your doctor may recommend some lifestyle changes such as stress-reducing programs, diet changes and exercise to assist in treatment and prevention of ulcers. This medicine should not be injected into your veins. 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. |
| Phonetic Pronunciation | (sue-KRAL-fate) |
| Precautions | PRECAUTIONS: Before taking sucralfate, 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 problems, stomach/intestine problems (such as delayed gastric emptying), tube feeding. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at greater risk for developing high aluminum levels while using this drug with other products that contain aluminum (such as antacids). If you are pregnant, tell your doctor before using sucralfate. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Constipation, dry mouth, upset stomach, gas, and nausea may occur. If any of these effects last or get worse, notify 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. Tell your doctor right away if you have any serious side effects, including: an unusual feeling of fullness in the stomach that doesn't go away, nausea/vomiting/stomach pain especially after meals. 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 | STORAGE: Store at room temperature away from light and moisture. 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: This medication is used to treat ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. |
Frequently Asked Questions (FAQs)
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SUCRALFATE 1 GM SUS 40X10 ML UD is manufactured by PHARMACEUTICAL ASSOC.
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