WARNINGS AND PRECAUTIONS

(5)· Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5).

(5)· Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms (5.14).

Side Effects

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.

What are the most common side effects of tadalafil?

If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Tadalafil (Cialis) will not be safe for you to take. Taking a nitrate medication for chest pain (angina) Taking guanylate cyclase (GC) stimulators, such as Adempas (riociguat) History of allergic reaction to other tadalafil medications (for example, Adcirca) The pill with imprint T20 (Yellow, Oval, 13 mm) has been identified as Tadalafil 20 mg and is used for Erectile Dysfunction, Benign Prostatic Hyperplasia, and Pulmonary Arterial Hypertension. (5)ADVERSE REACTIONSMost common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia,

nasal congestion, flushing, and pain in limb (6.1).To report SUSPECTED ADVERSE REACTIONS, contact

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Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1).History of known serious hypersensitivity reaction to tadalafil tablets or Adcirca®(4.2).Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). WARNINGS AND PRECAUTIONS· Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1). (5)· Use of tadalafil tablets with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). (5)· Tadalafil tablets are not recommended in combination with alpha- blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers.

How ED meds work: A refresher

(2.7, 5.6, 7.1, 12.2) (5)· Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil tablets with caution in patients predisposed to priapism (5.3). (5)· Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION (5.4, 6.2). Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS· Tadalafil tablets

can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol (7.1).

2.6 Use in Specific Populations

It belongs to the drug classes agents for pulmonary hypertension, impotence medications and is not a controlled substance. Tadalafil (Erectile Dysfunction, Benign Prostatic Hyperplasia) monograph Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If your selected quantity is intended to last longer than one month, please recheck the price using the 3-months supply option. In some cases, the estimated drug price may vary depending on the supply duration. You may find alternative ways to save with this medication.

Erectile dysfunction

Talk to your pharmacist about the potential option(s) noted below. View images of TADALAFIL (Generic for ADCIRCA) and identify pills by imprint, color or shape. If you need to save money on your TADALAFIL (Generic for ADCIRCA), compare our prices. Our prescription savings may even be lower than your insurance copay! Note: Multiple images may be best viagra for men displayed for medicines available in different strengths, sold under different brand names, or manufactured by different pharmaceutical companies. ketoconazole, ritonavir) increase tadalafil tablets exposure (2.7, 5.10, 7.2) requiring dose adjustment: (7)· Tadalafil tablets for use as needed: no more than

2.4 Dosage Adjustments Due to Drug Interactions

NDC Code(s): 62332-177-15, 62332-177-30, 62332-177-71, 62332-177-91, view more62332-178-15, 62332-178-30, 62332-178-71, 62332-178-91, 62332-179-30, 62332-179-71, 62332-179-91, 62332-180-30, 62332-180-71, 62332-180-91 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS.TADALAFIL tablets, for oral useInitial U.S. Approval: 2003INDICATIONS AND USAGETadalafil tablets USP are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: (1)· erectile dysfunction (ED) (1.1) (1)· the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) (1)· ED and the signs and symptoms of BPH (ED/BPH) (1.3) (1)If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4). (1)DOSAGE AND ADMINISTRATION•Tadalafil tablets for use as needed:•ED: Starting dose: 10 mg as needed prior to sexual activity.Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability.

Are you currently using Tadalafil (Cialis, Adcirca, and others)?

Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day (2.1).•Tadalafil tablet for once daily use:•ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (2.2).•BPH: 5 mg, taken at approximately the same time every day (2.3)•ED and BPH: 5 mg, taken at approximately the same time every day (2.3, 2.4)•Tadalafil tablets may be taken without regard to food (2.5). (2)DOSAGE FORMS AND STRENGTHSTablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3). (3)CONTRAINDICATIONSAdministration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. 10 mg every 72 hours (7)· Tadalafil tablet for once daily use: dose not to exceed 2.5 mg (7)· CYP3A4 inducers (e.g. rifampin) decrease tadalafil tablets exposure (7.2).

• The yellow Viagra pill is sometimes marketed as a generic or branded version.
• Its effectiveness depends on the individual's health and dosage taken.
• Store the pill in a cool, dry place away from direct sunlight.
• The pill may be taken with or without food, but high-fat meals can delay effects.
• Some yellow Viagra tablets contain 25mg, 50mg, or 100mg of sildenafil.
• Always follow prescribed doses; overdosing can lead to severe health risks.

(7)USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, 5.8, 8.6): (8)· Mild or Moderate: Dosage adjustment may be needed.

• The impact of the yellow Viagra pill can vary based on physical health and age.
• Its use is not recommended for individuals taking certain antifungals or antibiotics.
• The pill is effective only if the underlying cause of ED is suitable for sildenafil.
• Discreet packaging is common for online purchases of yellow Viagra pills.
• The pill’s effectiveness may diminish over time or with inconsistent use.
• Consult your doctor if you experience no results or adverse effects.

(8)Renal Impairment (2.6, 5.7, 8.7): (8)· Patients with creatinine clearance 30 mL/min to 50 mL/min: Dosage adjustment may be needed.

• The yellow Viagra pill is usually taken about an hour before sexual activity.
• Its effects can last for approximately 4 to 6 hours.
• Individuals taking other medications should check for potential drug interactions.
• Yellow Viagra can improve confidence and usability in sexual performance.
• It is not intended for use by women or children.
• Regular use without medical advice can lead to dependency or health issues.

(8)· Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours.

12.2 Pharmacodynamics

It can cause your blood pressure to drop too low. Tadalafil (Cialis) can also interact with blood pressure medications. Other drug interactions are with certain antifungals and antivirals like ritonavir (Norvir). Some interactions can raise the risk of other side effects like headaches and flushing. It's important to tell your prescriber and pharmacist about all the medications you take and plan to take.

Professional resources

Your care team can check that they're all safe to take together. They can adjust your medications or give you specific instructions on how to take them to keep you safe. Erectile dysfunction (ED) only When taken as needed: The typical starting dose is 10 mg by mouth at least 30 minutes before sexual activity. Take the medication only up to once per day, even if you have sex more than once in a day. Your prescriber will adjust your dose based on how well it's working for you and if you have side effects. (8)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 2/2025 Tadalafil tablets USP are phosphodiesterase 5

(PDE5) inhibitor indicated for the treatment of: (1) · the signs and symptoms of benign prostatic hyperplasia (BPH)

• 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.

(1.2) (1) · ED and the signs and symptoms of BPH (ED/BPH) (1.3) (1) If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4).

17.1 Nitrates

When taken daily: The typical starting dose is 2.5 mg by mouth at the same time every day, without regard to timing of sexual activity. Your prescriber will adjust the dose depending on how well it's working for you and any side effects. When taken as needed: The typical starting dose is 10 mg by mouth at least 30 minutes before sexual activity. Benign prostatic hyperplasia (BPH) only or BPH with ED When taken daily: The typical dose is 5 mg by mouth at the same time every day. Your dose might differ if you have liver or kidney problems.

Recreational use

It also might be different if you take certain medications that interact with tadalafil (Cialis). GoodRx has partnered with to provide reviews on the different aspects of Tadalafil (Cialis). Learn more about the effectiveness of Tadalafil (Cialis) based on real life experiences. Based on 34 people taking this medication Based on 65 people taking this medication Based on 28 people who have taken this medication Based on 80 people who have taken this medication Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary.