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TADALAFIL 5 MG TAB 30

  • Manufacturer Name : Amneal
  • MFG # : 69238134703
  • NDC : 69238134703
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description N
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category -
Drug Category USES: Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.
Drug Type Code COMMON BRAND NAME(S): Cialis
Drug Type Code N
FDA Approval Date 03/27/2019
FDA Therap Equiv TAB
HCPCS -
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date (tah-DA-la-fil)
Unit 30
Units Per Pkg 03/26/2019
Active Ingredients 9874 tadalafil 171596295
Active Ingredients 9874 tadalafil 171596295
AHFS Class 24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS; 48480000 VASODILATING AGENTS (RESPIRATORY TRACT); 48482400 PHOSPHODIESTERASE-5 INHIBITORS (RESPIR)
AHFS Class 24121200 PHOSPHODIESTERASE TYPE 5 INHIBITORS; 48480000 VASODILATING AGENTS (RESPIRATORY TRACT); 48482400 PHOSPHODIESTERASE-5 INHIBITORS (RESPIR)
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 53296 tadalafil ORAL TABLET 5 MG
Gen Code and Des 53296 tadalafil ORAL TABLET 5 MG
Inactive Ingredients 2432 lactose 64044515
Inactive Ingredients 2432 lactose 64044515
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 5MG
Strength 5MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Cialis
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: riociguat, vericiguat. Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use any of the following with tadalafil or within 48 hours of your last dose of tadalafil: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite. If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of tadalafil or adjust your alpha blocker medication to minimize your risk of low blood pressure. Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir), rifampin, ritonavir, among others. Do not take this medication with any other product that contains tadalafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).
Allocation Period -
Allocation Period -
Case Quantity 24
Case Quantity 24
Drug Form Pack Size 30
Drug Form Pack Size 30
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 30
Unit Size 30
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth, with or without food, as directed by your doctor. Do not take tadalafil more often than once daily. The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's directions on how to take this medication. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To treat the symptoms of BPH, take this medication as directed by your doctor, usually once a day. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should continue taking this medication. To treat erectile dysfunction-ED, there are 2 ways that tadalafil may be prescribed. Your doctor will determine which is the best way for you to take tadalafil. Follow your doctor's directions exactly since your dosage depends on how you are taking it. The first way is to take it as needed, usually at least 30 minutes before sexual activity. Tadalafil's effect on sexual ability may last up to 36 hours. The second way to treat ED is to take tadalafil regularly, once a day every day. If you take it this way, you may attempt sexual activity at any time between your doses. If you are taking tadalafil to treat both ED and BPH, take it as directed by your doctor, usually once a day. You may attempt sexual activity at any time between your doses. If you are taking tadalafil once daily for BPH, or for ED, or for both, take it regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose 30
Missed Dose MISSED DOSE: If you are taking this medication on a regular schedule and 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.
Notes TAB
Overdose AB
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 (tah-DA-la-fil)
Phonetic Pronunciation -
Precautions -
Precautions PRECAUTIONS: Before taking tadalafil, 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: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. 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). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This brand of the drug is not usually used in women. During pregnancy, tadalafil should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects -
Side Effects SIDE EFFECTS: Headache, stomach upset, back pain, muscle pain, stuffy nose, flushing, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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. Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea. Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke. Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur. In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur. 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 03/26/2019
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 USES: Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.

Frequently Asked Questions(FAQs)

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TADALAFIL 5 MG TAB 30 is manufactured by Amneal.
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