Sildenafil Citrate

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
• However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1 ) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1 ) Maximum recommended dosing frequency is once per day ( 2.1 )
• 2.1 Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
• However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity.
• The maximum recommended dosing frequency is once per day.
• Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.
• 2.2 Use with Food Sildenafil tablets may be taken with or without food.
• 2.3 Dosage Adjustments in Specific Situations Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1) , Drug Interactions (7.1) , and Clinical Pharmacology (12.2) ].
• When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5) , Drug Interactions (7.2) , and Clinical Pharmacology (12.2) ].
• 2.4 Dosage Adjustments Due to Drug Interactions Ritonavir The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ].
• CYP3A4 Inhibitors Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.
• Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [ see Drug Interactions (7.4) and Clinical Pharmacology (12.3) ].
• 2.5 Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and patients with severe renal impairment (creatinine clearance <30 mL/minute) because administration of sildenafil tablets in these patients resulted in higher plasma levels of sildenafil [ see Use in Specific Populations (8.5 , 8.6, 8.7) and Clinical Pharmacology (12.3) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Sildenafil is not indicated for use in pediatric patients. Safety and effectiveness have not been established in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil resulting in approximately 84% and 107% higher plasma AUC values of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy young volunteers (18-45 years) [ see Clinical Pharmacology (12.3) ].
• Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively [ see Clinical Pharmacology (12.3) ].
• Of the total number of subjects in clinical studies of sildenafil, 18% were 65 years and older, while 2% were 75 years and older.
• No overall differences in safety or efficacy were observed between older (≥ 65 years of age) and younger (< 65 years of age) subjects.
• However, since higher plasma levels may increase the incidence of adverse reactions, a starting dose of 25 mg should be considered in older subjects due to the higher systemic exposure [ see Dosage and Administration (2.5) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following are discussed in more detail in other sections of the labeling:
• Cardiovascular [ see Warnings and Precautions (5.1) ] Prolonged Erection and Priapism [ see Warnings and Precautions (5.2) ] Effects on the Eye [ see Warnings and Precautions (5.3) ] Hearing Loss [ see Warnings and Precautions (5.4) ] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [ see Warnings and Precautions (5.5) ] Adverse Reactions with the Concomitant Use of Ritonavir [ see Warnings and Precautions (5.6) ] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [ see Warnings and Precautions (5.7) ] Effects on Bleeding [ see Warnings and Precautions (5.8) ] Counseling Patients About Sexually Transmitted Diseases [ see Warnings and Precautions (5.9) ] The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
• Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Umedica Laboratories USA Inc. at 1-855-288-5777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• Sildenafil was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide.
• Over 550 patients were treated for longer than one year.
• In placebo-controlled clinical studies, the discontinuation rate due to adverse reactions for sildenafil (2.5%) was not significantly different from placebo (2.3%).
• In fixed-dose studies, the incidence of some adverse reactions increased with dose.
• The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed- dose studies.
• At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.
• Table 1:
• Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Fixed-Dose Phase II/III Studies Adverse Reaction 25 mg (n=312) 50 mg (n=511) 100 mg (n=506) Placebo (n=607) Headache 16% 21% 28% 7% Flushing 10% 19% 18% 2% Dyspepsia 3% 9% 17% 2% Abnormal vision† 1% 2% 11% 1% Nasal congestion 4% 4% 9% 2% Back pain 3% 4% 4% 2% Myalgia 2% 2% 4% 1% Nausea 2% 3% 3% 1% Dizziness 3% 4% 3% 2% Rash 1% 2% 3% 1% † Abnormal Vision:
• Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.
• When sildenafil was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took sildenafil at least once weekly, and the following adverse reactions were reported:
• Table 2.
• Adverse Reactions Reported by ≥2% of Patients Treated with sildenafil and More Frequent than Placebo in Flexible-Dose Phase II/III Studies Adverse Reaction SILDENAFIL CITRATE PLACEBO N=734 N=725 Headache 16% 4% Flushing 10% 1% Dyspepsia 7% 2% Nasal Congestion 4% 2% Abnormal Vision † 3% 0% Back pain 2% 2% Dizziness 2% 1% Rash 2% 1% † Abnormal Vision:
• Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision.
• In these studies, only one patient discontinued due to abnormal vision.
• The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil is uncertain.
• Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful:
• Body as a Whole:
• face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
• Cardiovascular:
• angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.
• Digestive:
• vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.
• Hemic and Lymphatic: anemia and leukopenia.
• Metabolic and Nutritional:
• thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.
• Musculoskeletal:
• arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
• Nervous:
• ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.
• Respiratory:
• asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
• Skin and Appendages:
• urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
• Special Senses:
• sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.
• Urogenital:
• cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.
• Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil with and without anti-hypertensive medication.
• This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of sildenafil .
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.
• Cardiovascular and cerebrovascular Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil.
• Most, but not all, of these patients had preexisting cardiovascular risk factors.
• Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity.
• Others were reported to have occurred hours to days after the use of sildenafil and sexual activity.
• It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1) and Patient Counseling Information (17) ].
• Hemic and Lymphatic:
• vaso-occlusive crisis:
• In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo.
• The clinical relevance of this finding to men treated with sildenafil for ED is not known.
• Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.
• Respiratory:
• epistaxis Special senses:
• Hearing:
• Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil.
• In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
• In many cases, medical follow-up information was limited.
• It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4) and Patient Counseling Information (17) ].
• Ocular:
• diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous traction/detachment.
• Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil.
• Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to:
• low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [ see Warnings and Precautions (5.3) and Patient Counseling Information (17) ].
• Urogenital:
• prolonged erection, priapism [ see Warnings and Precautions (5.2) and Patient Counseling Information (17) ], and hematuria.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information) Nitrates Physicians should discuss with patients the contraindication of sildenafil 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) Stimulators Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3) ].
• Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
• Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients.
• Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [ see Warnings and Precautions (5.5) ].
• Cardiovascular Considerations Physicians 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 Vision Physicians should advise patients to
• stop use of all PDE5 inhibitors, including sildenafil, 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 discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.
• 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, for this uncommon condition [ see Warnings and Precautions (5.3) and Adverse Reactions (6.2) ].
• Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
• These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil.
• 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) ].
• Priapism Physicians 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.
• In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
• 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 Inhibitors Physicians 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 Disease The use of sildenafil 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 by: Umedica Laboratories Pvt.
• Ltd.
• Vapi, Gujarat 396195, INDIA.
• Distributed by: Umedica Laboratories USA Inc.
• Parsippany, NJ, 07054.
• Product of India Revised:
• December 2025, V-00 Patient Information Sildenafil (sil den' a fil ) Tablets USP 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 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.
• 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 tablets are a prescription medicine used to treat erectile dysfunction (ED).
• 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.
• 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 conditions Tell 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.
• Especially tell your healthcare provider
• if you take any of the following:
• medicines called nitrates (see “What is the most important information I should know about sildenafil tablets?” ) medicines called guanylate cyclase stimulators, such as riociguat (Adempas) medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).
• Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure.
• In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox) some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin other medicines that treat high blood pressure other medicines or treatments for ED Sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO.
• REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH).
• Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).
• Ask your healthcare provider or pharmacist for a list of these medicines,
• if you are not sure.
• Know the medicines you take.
• Keep a list of them to show to your healthcare provider and pharmacist when
• you get a new medicine.
• How should I take sildenafil tablets? Take sildenafil tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.
• Your healthcare provider may change your dose if needed.
• Take sildenafil tablets about 1 hour before sexual activity.
• You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.
• Sildenafil tablets can be taken with or without food.
• If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working
• Do not take sildenafil tablets more than 1 time a day.
• If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.
• What are the possible side effects of sildenafil tablets? Sildenafil tablets can cause serious side effects.
• Rarely reported side effects include: an erection that will not go away (priapism).
• If you have an erection that lasts more than 4 hours, get medical help right away.
• If it is not treated right away, priapism can permanently damage your penis. sudden vision loss in one or both eyes.
• Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).
• It is uncertain whether PDE5 inhibitors directly cause the vision loss.
• Stop taking sildenafil tablets and call your healthcare provider right away
• if you have sudden vision loss in one or both eyes. sudden hearing decrease or hearing loss .
• Some people may also have ringing in their ears (tinnitus) or dizziness.
• If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.
• The most common side effects of sildenafil tablets are:
• headache flushing upset stomach abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision stuffy or runny nose back pain muscle pain nausea dizziness rash In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets.
• Most, but not all, of these men had heart problems before taking sildenafil tablets.
• It is not known if sildenafil tablets caused these problems.
• Tell your healthcare provider
• if you have any side effect that bothers you or does not go away.
• These are not all the possible side effects of sildenafil tablets.
• For more information, ask your healthcare provider or pharmacist.
• Call your doctor for medical advice about side effects.
• You may report side effects to FDA at 1­-800-FDA-1088.
• How should I store sildenafil tablets? Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep sildenafil tablets and all medicines out of the reach of children.
• General information about the safe and effective use of sildenafil tablets.
• Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
• Do not use sildenafil tablets for a condition for which it was not prescribed.
• Do not give sildenafil tablets to other people, even if they have the same symptoms that
• you have.
• It may harm them.
• This Patient Information leaflet summarizes the most important information about sildenafil tablets.
• If you would like more information, talk with your healthcare provider.
• You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.
• For more information, call Umedica Laboratories USA Inc. at 1-855-288-5777.
• What are the ingredients in sildenafil tablets? Active ingredient:
• sildenafil citrate, USP Inactive ingredients:
• colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.
• This Patient Information has been approved by the U.S.
• Food and Drug Administration.
• Manufactured by: Umedica Laboratories Pvt.
• Ltd.
• Vapi, Gujarat 396195, INDIA.
• Distributed by: Umedica Laboratories USA Inc.
• Parsippany, NJ, 07054.
• Product of India Revised:
• December 2025, V-00 * The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt.
• Ltd.
• The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt.
• Ltd. or its products.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Sildenafil tablets, USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate USP equivalent to 50 mg, or 100 mg of sildenafil.
• Tablets are debossed with 1A1 and 1A2 on one side and plain on the other to indicate the dosage strengths viz. 100 mg and 50 mg respectively.
• Sildenafil tablets 25 mg USP is supplied as Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side.
• Tablets: 25 mg, 50 mg and 100 mg

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Sildenafil tablets USP are supplied as pale blue to blue, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:
• For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side.
• For 50 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A2’ on one side and plain on other side.
• For 25 mg - Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side. 25 mg 50 mg 100 mg Bottle of 30 tablets NDC 60290-079-01 NDC 60290-002-01 NDC 60290-003-01 Bottle of 90 tablets NDC 60290-079-02 - - Bottle of 100 tablets - NDC 60290-002-02 NDC 60290-003-02 Bottle of 500 tablets NDC 60290-079-04 NDC 60290-002-04 NDC 60290-003-04 Bottle of 1000 tablets NDC 60290-079-03 NDC 60290-002-03 NDC 60290-003-03 Bottle of 4000 tablets - - NDC 60290-003-05 Recommended Storage:
• Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

• Sildenafil tablets, USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
• Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo[4,3- d ]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
• Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.
• Sildenafil tablets USP are formulated as pale blue to blue film-coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration.
• Sildenafil tablets 50 mg and 100 mg are caplet shaped whereas sildenafil tablets 25 mg are round shaped.
• In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients:
• colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. sildenafil-citrate-structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

62 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Sildenafil Citrate