SC 20 Pill: white, round, 7mm

Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity.

In case of emergency/overdose

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases.

What are the serious side effects of sildenafil?

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Manufactured for:Camber Pharmaceuticals, Inc.,Piscataway, NJ 08854by: HETERO TMHetero Labs LimitedJeedimetla, Hyderabad - 500 055, India.Revised: 12/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Patient Information Patient InformationSildenafil Tablets, USP(sil den' a fil)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sildenafil citrate tablets 50mg sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine.

Interactions that increase your risk for side effects

Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called ''nitrates” (such as nitroglycerin)• use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take sildenafil tablets, tell your healthcare provider if you:• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure• have had heart surgery within the last 6 months• have pulmonary hypertension• have had a stroke• have low blood pressure, or high blood pressure that is not controlled• have a deformed penis shape• have had an erection that lasted for more than 4 hours• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia• have retinitis pigmentosa, a rare genetic (runs in families) eye disease• have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)• have bleeding problems• have or have had stomach ulcers• have liver problems• have kidney problems or are having kidney dialysis• have any other medical conditionsTell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° sildenafil citrate drug to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

• Sildenafil tablets are often stored in their original packaging to avoid contamination.
• Use only the amount prescribed; more does not mean better results.
• Sildenafil helps improve erectile function but doesn’t increase libido.
• The tablets are designed for rapid and effective absorption.
• Always inform your doctor about existing health conditions before use.
• Some brands of sildenafil are marketed as "white tablets" for easy recognition.
• The medication can cause a mild increase in blood flow to other body parts.
• Avoid caffeine or heavy meals before taking sildenafil for better results.
• The safety and efficacy of sildenafil are supported by numerous clinical trials.
• Never take expired sildenafil tablets, as their safety can’t be guaranteed.
• Regular blood pressure checks are recommended when using sildenafil long-term.

Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden sildenafil citrate tablets 200mg Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

Key takeaways:

Professional resources

Sildenafil vs. tadalafil

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

Detection in biological fluids

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets.

• Sildenafil tablets are specifically formulated to mitigate potential side effects.
• The tablet's white color is typical for certain dosages or brands.
• Patients with cardiovascular issues should consult a doctor before use.
• Sildenafil is sometimes used to treat certain cases of erectile dysfunction caused by depression medication.
• The effects of sildenafil can be enhanced by reducing alcohol intake.
• Contraceptive methods do not impact sildenafil's effectiveness.
• Sildenafil does not cause spontaneous erections without sexual stimulation.
• It is important to remain seated or relaxed after taking sildenafil.
• The pill’s manufacturing process includes strict quality control protocols.
• Beware of unregulated markets selling unverified sildenafil tablets.
• Follow dosing instructions carefully to prevent overdose or underdose.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

2.1 Dosage Information

Recreational use

How it works for PAH

Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Manufactured for:Camber Pharmaceuticals, Inc.,Piscataway, NJ 08854by: HETERO TMHetero Labs LimitedJeedimetla, Hyderabad - 500 055, India.Revised: 12/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Patient Information Patient InformationSildenafil Tablets, USP(sil den' a fil)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sildenafil citrate tablets 50mg sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED).

How much does Sildenafil (Revatio) cost?

Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Effectiveness by condition:

Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° sildenafil citrate drug to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side.

Your expert team

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden sildenafil citrate tablets 200mg Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. You will not get an erection just by taking this medicine.

Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called ''nitrates” (such as nitroglycerin)• use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.

Risks and warnings for Sildenafil (Viagra)

See the end of this leaflet for a complete list of ingredients in sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take sildenafil tablets, tell your healthcare provider if you:• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure• have had heart surgery within the last 6 months• have pulmonary hypertension• have had a stroke• have low blood pressure, or high blood pressure that is not controlled• have a deformed penis shape• have had an erection that lasted for more than 4 hours• have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia• have retinitis pigmentosa, a rare genetic (runs in families) eye disease• have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)• have bleeding problems• have or have had stomach ulcers• have liver problems• have kidney problems or are having kidney dialysis• have any other medical conditionsTell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects.