3 DOSAGE FORMS AND STRENGTHS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets LabelSildenafil Citrate Tablets 25 mg - NDC 75834-272-00

• Sildenafil 200 mg's safety profile depends on individual health conditions.
• It is important to inform your doctor of all medications being taken.
• Use sildenafil only when needed for sexual activity.
• Avoid engaging in activities that require alertness until effects are known.
• The drug is often part of a broader erectile dysfunction treatment strategy.
• Safe storage is essential to prevent accidental ingestion by children or others.

- 1000 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500

• Sildenafil 200 mg may cause visual disturbances like blurred vision.
• Consult your doctor if side effects persist or worsen.
• Avoid grapefruit or grapefruit juice while taking sildenafil.
• This medication should only be used under medical supervision.
• Sildenafil is also used to treat pulmonary arterial hypertension.
• Do not share sildenafil 200 mg with others.

Tablets LabelSildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000 Tablets LabelSildenafil Citrate Tablets 100 mg

5. Warnings and Precautions

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? 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 low blood pressure, or high blood pressure that is not controlled 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 kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements. medicines called nitrates (see “What is the most importantinformation 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). In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting.

When is the best time to take Viagra?

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 Sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO. 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. Take sildenafil citrate 100mg tablets 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. - NDC 75834-241-30 - 30 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets LabelSildenafil

Patient Group	Recommended Dosage	Administration Tips	Contraindications
Adult Men with ED	200 mg once daily	Take 30-60 min before activity	Nitrate medication use, severe liver impairment
Pulmonary Hypertension	20 mg three times daily	Take with water, on an empty stomach	Concurrent use of compatible medications
Elderly Patients	Start with lower doses	Adjust based on response	Liver or kidney impairment
Patients with Kidney Disease	Dose adjustment may be needed	Follow physician instructions	Severe renal impairment

Citrate Tablets 100 mg - NDC 75834-241-05 - 500 Tablets LabelSildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-30 - 30 Tablets Label Sildenafil

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Citrate Tablets 25 mg - NDC 75834-272-90 - 90 Tablets Label Sildenafil Citrate Tablets 25 mg - NDC 75834-272-00 - 1000 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-30 - 30 Tablets

Side Effect	Frequency	Severity	Management Suggestions
Headache	Common	Mild	Analgesics, hydration
Visual disturbances	Less common	Mild-moderate	Discontinue use if persistent
Dizziness	Common	Mild	Sit or lie down, avoid driving
Priapism	Rare	Severe	Seek immediate medical attention
Hearing loss	Very rare	Severe	Discontinue medication, seek help

Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-01 - 100 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-05 - 500 Tablets Label Sildenafil Citrate Tablets 50 mg - NDC 75834-240-00 - 1000

2.1 Dosage Information

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 nottake sildenafil tablets more than 1 time a day.

Patient resources

If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away. 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). Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-30 - 30 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-01 - 100 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-05 -

2.4 Dosage Adjustments Due to Drug Interactions

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 Nivagen Pharmaceuticals, Inc.

5.1 Cardiovascular

at 1-877-977-0687.What are the ingredients in sildenafil tablets?Active ingredient:sildenafil citrate, USPInactive 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. 221 and 221/1, GIDC, II sildenafil cenforce ndPhase,Vapi, Gujarat 396195, India (IND)Manufactured for:Nivagen Pharmaceuticals, Inc.Sacramento, CA 95827, USAToll free number: 1-877-977-0687Revised: June 2023, V-03*The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Advise the patient to read the FDA-approved patient labeling (Patient Information) 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. 500 Tablets Label Sildenafil Citrate Tablets 100 mg - NDC 75834-241-00 - 1000 Tablets Label INGREDIENTS AND APPEARANCE Inactive IngredientsMAGNESIUM STEARATE (UNII: 70097M6I30)HYPROMELLOSES (UNII: 3NXW29V3WO)TITANIUM DIOXIDE (UNII: 15FIX9V2JP)LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)TRIACETIN (UNII: XHX3C3X673)FD&C BLUE NO.

Parameter	Description	Typical Values	Notes
Absorption	Time to peak plasma concentration (Tmax)	30-120 minutes	Taken on an empty stomach for faster absorption
Bioavailability	Percentage absorbed into bloodstream	40%	Affected by food intake
Half-life	Duration for plasma concentration to reduce by half	4 hours	Determines dosing frequency
Metabolism	Liver enzyme involved	CYP3A4	Also metabolized by CYP2C9

2 (UNII: L06K8R7DQK)Product CharacteristicsColorblueScoreno scoreShapeROUNDSize7mmFlavorImprint Code25;SLContainsPackagingNDC:75834-272-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021NDC:75834-272-9090 in 1 BOTTLE; Type

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

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.

What Is the Maximum Safe Sildenafil Dosage?

If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.The most common side effects of sildenafil tablets are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn 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. 0: Not a Combination Product06/16/2021NDC:75834-272-001000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021Marketing InformationANDAANDA20930206/16/2021Labeler - NIVAGEN PHARMACEUTICALS, INC.

10. Overdosage

If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. It is not known if sildenafil tablets caused these problems. 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.