T20 Pill: yellow, oval, 13mm

At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.

• Yellow Viagra should be stored out of reach of children and pets.
• It is not suitable for use in individuals with severe hypotension or stroke history.
• The medication can cause priapism, a prolonged erection that requires medical attention.
• Do not take yellow Viagra if you are allergic to sildenafil or other ingredients.
• The pill's nutritional compatibility is generally unaffected by diet unless high-fat.
• Discontinue use and seek medical help if adverse reactions occur.

One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted.

5.1 Cardiovascular

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.

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Efficacy Results in Subpopulations in Controlled Clinical Studies 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

16.2 Storage

Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

• The yellow color of the pill is mainly for identification and branding purposes.
• Viagra was first approved by the FDA in 1998 for ED treatment.
• Some pills labeled as "yellow Viagra" may contain different active ingredients.
• Always ensure the pill's packaging matches the prescription or supplier's info.
• The pill may cause vision changes, such as increased light sensitivity or blurred vision.
• Taking multiple pills or higher doses can increase the risk of adverse reactions.

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)].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 viagra vardenafil 20mg administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients.

Purpose	Recommended Dosage	Typical Onset	Duration of Effect	Notes
Erectile Dysfunction	50-100 mg	30-60 min	4-6 hours	Taken with water
Pulmonary Hypertension	25 mg	15-30 min	4 hours	Prescribed by doctor
Recreational Use	50-100 mg	30-60 min	4-6 hours	Off-label, caution advised

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 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.

Country	Legal Status	Prescription Requirement	Remarks
USA	Prescription required	Yes	FDA approved brands only
UK	Prescription required	Yes	Controlled prescription
Canada	Prescription required	Yes	Similar to US
Australia	Prescription required	Yes	Strict regulations

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.

User	Experience	Satisfaction Level	Comments
John D.	Improved performance	4/5	Works well, fast action
Mike S.	Mild side effects	3/5	Effective but slight headache
Alan P.	Quick onset	5/5	Very effective, no issues
David L.	Not effective	2/5	Did not see desired results

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.

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Efficacy Results in Subpopulations in Controlled Clinical Studies 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Sildenafil tablets, USP are supplied as green, oval-shaped, beveled edge, biconvex, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). 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)].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 viagra vardenafil 20mg 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.

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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 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. 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. 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)].Product of IndiaManufactured by:Ajanta Pharma Limited, IndiaMarketed by:Ajanta Pharma USA Inc.Bridgewater, NJ 08807.Revised: 10/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat 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).

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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 chronic-thromboembolic 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 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.

• The manufacturing date and expiry date are critical for pill safety.
• Yellow Viagra pills can sometimes be found in various doses, requiring cautious use.
• Combining Viagra with recreational drugs can cause dangerous interactions.
• Medical professionals recommend a thorough health assessment before starting treatment.
• The pill may cause temporary changes in vision, requiring caution during activities.
• Use only as directed by a healthcare provider to minimize risks.

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets do not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED).

5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

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)].Product of IndiaManufactured by:Ajanta Pharma Limited, IndiaMarketed by:Ajanta Pharma USA Inc.Bridgewater, NJ 08807.Revised: 10/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat 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 chronic-thromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.

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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 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 do not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablet 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 is 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 nitratetake 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 failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave 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 tablets works causing side effects. You will not get an erection just by taking this medicine.

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Sildenafil tablet 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 is 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 nitratetake 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 failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave 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 tablets works causing side effects.

5.9 Alcohol

At the end of the long-term study, 88% of patients reported that sildenafil tablets improved their erections. Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF. Sildenafil tablets improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction. One randomized, double-blind, flexible-dose, placebo-controlled study included only patients with erectile dysfunction attributed to complications of diabetes mellitus (n=268). Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.

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One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. 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.