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PROGESTERONE 100 MG CAP 100

  • Manufacturer Name : Xiromed LLC
  • MFG # : 70700016201
  • NDC : 70700016201
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind AB
DESI2 Drug Ind -
Drug Category N
Drug Category -
Drug Type Code N
Drug Type Code 1
FDA Approval Date 10/20/2017
FDA Approval Date 01/01/2021
FDA Therap Equiv CAP
FDA Therap Equiv AB
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date 01/01/2021
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Unit CAP
Unit 100
Units Per Pkg 10/20/2017
Units Per Pkg 100
Active Ingredients 7971 progesterone, micronized
Active Ingredients 7971 progesterone, micronized
AHFS Class 68320000 PROGESTINS
AHFS Class 68320000 PROGESTINS
DEA Class NC
DEA Class NC
Dose Form CAPSULE
Dose Form CAPSULE
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 43801 progesterone, micronized ORAL CAPSULE 100 MG
Gen Code and Des 43801 progesterone, micronized ORAL CAPSULE 100 MG
Inactive Ingredients 13405 soy; 2549 gelatin 9000708; 568 peanut
Inactive Ingredients 13405 soy; 2549 gelatin 9000708; 568 peanut
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 100MG
Strength 100MG
Common Brand Name COMMON BRAND NAME(S): Prometrium
Common Brand Name COMMON BRAND NAME(S): Prometrium
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. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
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. This medication may interfere with certain lab 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 40
Case Quantity 40
Drug Form Pack Size 100
Drug Form Pack Size 100
Form CAPSULES
Form CAPSULES
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
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 100
Unit Size 100
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once a day at bedtime. If you have trouble swallowing the pills, take with a full glass of water while standing up. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy. Inform your doctor if your condition does not improve or if it worsens.
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once a day at bedtime. If you have trouble swallowing the pills, take with a full glass of water while standing up. Follow the dosing schedule carefully. Ask your doctor if you have any questions. The dosage is based on your medical condition and response to therapy. Inform your doctor if your condition does not improve or if it worsens.
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 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: Do not share this medication with others. Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Regular complete physical exams which include lab and/or medical tests (such as blood pressure, breast exam/mammogram, pelvic exam, Pap smear) should be done while you are taking this medication. Follow your doctor's instructions for examining your breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.
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 severe nausea and vomiting.
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 severe nausea and vomiting.
Phonetic Pronunciation (pro-JESS-ter-own)
Phonetic Pronunciation (pro-JESS-ter-own)
Precautions PRECAUTIONS: Before taking progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), 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: blood clots, history of bleeding in the brain, liver disease, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), personal or family history of cancer (especially breast or other female organs), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes, lupus. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details. Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks. This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. This medication may be used during pregnancy only as directed by your doctor. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking progesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), 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: blood clots, history of bleeding in the brain, liver disease, vaginal bleeding of unknown cause, a loss of pregnancy with some tissue remaining in the uterus ("missed abortion"), personal or family history of cancer (especially breast or other female organs), kidney disease, obesity, heart disease (such as past heart attacks, coronary artery disease, heart failure), high blood pressure, seizures, migraine headaches, asthma, high blood levels of cholesterol/fats, depression, diabetes, strokes, lupus. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (such as on a long plane flight). You may need to stop the medication for a time or take special precautions because of the increased risk for blood clots. Ask your doctor for more details. Do not smoke. Smoking combined with this medication further increases your risk for strokes, blood clots, high blood pressure, and heart attacks. This medication may cause blotchy, dark areas on your face and skin (melasma). Sunlight may worsen this effect. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. This medication may be used during pregnancy only as directed by your doctor. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness 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: nausea/vomiting that doesn't stop, unusual vaginal bleeding (such as spotting, breakthrough bleeding), mental/mood changes (such as depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness. This medication may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs, blindness). Get medical help right away if any of these very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, difficulty walking, sudden vision changes (such as blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch. 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 SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, or drowsiness 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: nausea/vomiting that doesn't stop, unusual vaginal bleeding (such as spotting, breakthrough bleeding), mental/mood changes (such as depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness. This medication may rarely cause very serious (possibly fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs, blindness). Get medical help right away if any of these very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, difficulty walking, sudden vision changes (such as blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch. 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.
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: Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (such as hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication is not for use in children. Progesterone must not be used to test for pregnancy.
Uses USES: Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (such as hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication is not for use in children. Progesterone must not be used to test for pregnancy.

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PROGESTERONE 100 MG CAP 100 is manufactured by Xiromed LLC.
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