Product Details
BONJESTA 20/20MG ER TAB 60
Manufacturer: DUCHESNAY USA INC
MFG#: 55494-0120-60
NDC: 55494-0120-60
PID: 257542
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Product Properties:
| Description | - |
|---|---|
| Description | S |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | S |
| Drug Category | USES: This combination medication contains 2 ingredients: doxylamine and pyridoxine. It is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (such as pregnancy, poor diet, alcoholism) can result in a lack of this vitamin. |
| Drug Type Code | COMMON BRAND NAME(S): Bonjesta |
| Drug Type Code | 1 |
| FDA Approval Date | 11/07/2016 |
| FDA Therap Equiv | NR |
| HCPCS | 1 |
| HCPCS | - |
| Market Entry Date | 04/02/2018 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (dox-IL-a-meen/PIR-i-DOX-een) |
| Termination Date | - |
| Unit | TAB |
| Units Per Pkg | 60 |
| Active Ingredients | 1058 pyridoxine HCl (vitamin B6) 58560; 3372 doxylamine succinate 562107 |
| Active Ingredients | 1058 pyridoxine HCl (vitamin B6) 58560; 3372 doxylamine succinate 562107 |
| AHFS Class | 56220800 ANTIHISTAMINES (GI DRUGS); 88080000 VITAMIN B COMPLEX; 48040400 FIRST GENERATION ANTIHIST.(RESPIR TRACT); 56229200 ANTIEMETICS, MISCELLANEOUS |
| AHFS Class | 56220800 ANTIHISTAMINES (GI DRUGS); 88080000 VITAMIN B COMPLEX; 48040400 FIRST GENERATION ANTIHIST.(RESPIR TRACT); 56229200 ANTIEMETICS, MISCELLANEOUS |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | TABLET,IMMEDIATE,DELAY RELEASE,BIPHASE |
| Dose Form | TABLET,IMMEDIATE,DELAY RELEASE,BIPHASE |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 76841 doxylamine succinate/vit B6 ORAL TAB IR DR 20 MG-20MG |
| Gen Code and Des | 76841 doxylamine succinate/vit B6 ORAL TAB IR DR 20 MG-20MG |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 11039 sodium bicarbonate 144558 |
| Inactive Ingredients | 10138 blue dye; 10141 red dye; 11039 sodium bicarbonate 144558 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 20/20MG E |
| Strength | 20/20MG E |
| Common Brand Name | COMMON BRAND NAME(S): Bonjesta |
| Common Brand Name | - |
| 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. Some products that may interact with this drug are: altretamine, antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray). Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain lab tests (such as urine drug screening tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug. |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 24 |
| Case Quantity | 24 |
| Drug Form Pack Size | 60 |
| Drug Form Pack Size | 60 |
| Form | TABLET |
| Form | TABLET |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit Size | 60 |
| Unit Size | 60 |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach with a glass of water as directed by your doctor, usually starting with once daily at bedtime. If your nausea lasts on the next day, your doctor may direct you to increase your dose to twice daily (in the morning and at bedtime). Do not take more than 2 tablets in a day. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. |
| How to Use | - |
| 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. |
| Missed Dose | 60 |
| Notes | TAB |
| Notes | NOTES: Do not share this medication with others. Do not take for several days before allergy testing because test results can be affected. |
| Overdose | NR |
| 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. Symptoms of overdose may include: restlessness, dry mouth, severe drowsiness, confusion, fast heartbeat, weakness, seizure. |
| Phonetic Pronunciation | (dox-IL-a-meen/PIR-i-DOX-een) |
| Phonetic Pronunciation | - |
| Precautions | - |
| Precautions | PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to doxylamine or pyridoxine; 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: breathing problems (such as asthma, emphysema), eye problems (such as glaucoma), stomach problems (such as ulcers, blockage), urination problems (such as urinary retention). This drug may make you dizzy or drowsy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This product is safe to use during pregnancy. Pyridoxine passes into breast milk. It is unknown if doxylamine passes into breast milk. However, similar drugs pass into breast milk. Doxylamine may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Drowsiness, dizziness, or blurred vision 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. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, irritability, nervousness), trouble urinating. 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. |
| Side Effects | - |
| 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. |
| Storage | 11/07/2016 |
| Uses | USES: This combination medication contains 2 ingredients: doxylamine and pyridoxine. It is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (such as pregnancy, poor diet, alcoholism) can result in a lack of this vitamin. |
| Uses | - |
Frequently Asked Questions (FAQs)
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BONJESTA 20/20MG ER TAB 60 is manufactured by DUCHESNAY USA INC.
You can purchase BONJESTA 20/20MG ER TAB 60 on our website at https://supplies.pipelinemedical.com/product/detail/bonjesta-20-20mg-er-tab-60-257542