Label: TADALAFIL tablet, coated

History of known serious hypersensitivity reaction to tadalafil tablets or Adcirca®(4.2). Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3). · Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status (5.1).

• Physical features of yellow Cialis include smooth coating and visible markings.
• Patients should avoid alcohol and grapefruit products while taking yellow Cialis.
• The yellow color of Cialis pills signifies it's a PDE5 inhibitor.
• The yellow Cialis pill is designed for quick absorption in the bloodstream.
• Before use, check the packaging for authenticity of the yellow Cialis.
• Side effects like dizziness may occur after taking yellow Cialis.
• The yellow Cialis pill is known for its consistency in quality.
• Cialis's active ingredient, tadalafil, is responsible for its effects.
• Always follow dosing guidelines to prevent potential health risks.
• The yellow Cialis pill enhances sexual performance by improving blood flow.
• Education about yellow Cialis helps patients use it effectively.
• Medical consultation is essential when considering yellow Cialis treatment.

· Use of tadalafil tablets with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). · 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. (2.7, 5.6, 7.1, 12.2) (5) · Patients should seek emergency treatment if an erection lasts >4 hours.

· 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).

16.1 How Supplied

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

Canadian Brand Name

(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). (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 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). 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 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). (7)USE IN SPECIFIC POPULATIONSHepatic Impairment (2.6, 5.8, 8.6): (8)· Mild or Moderate: Dosage adjustment may be needed. · Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (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). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1).

Which Makes You Harder?

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems. Do not use this medicine if you are also using riociguat (Adempas®) or a nitrate medicine, often used to treat angina (chest pain).

What CIALIS contains

Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If you need to use a nitrate medicine, take it at least 48 hours after your last dose of tadalafil. Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure. If you experience sudden loss of vision in one or both eyes, contact your doctor immediately.

What should I do if I accidentally use too much tadalafil?

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. 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. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or · Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol (7.1). 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 10 mg every 72 hours (7) · Tadalafil tablet for once daily use: dose not to exceed 2.5 mg (7) rifampin) decrease tadalafil tablets exposure (7.2). Hepatic Impairment (2.6, 5.8, 8.6): (8) · Mild or Moderate: Dosage adjustment may be needed.

• The yellow Cialis pill is often preferred for its long-lasting effects.
• It is important to disclose health conditions to your doctor before using yellow Cialis.
• Yellow Cialis is sometimes used off-label for other conditions, under supervision.
• The pill's color and markings help pharmacy staff identify the correct medication.
• Cialis (yellow pills) should ideally be taken in a relaxed environment.
• Dosage frequency of yellow Cialis varies according to individual needs.
• The yellow Cialis pill is part of a class of drugs enhancing erectile response.
• Side effects are often mild but should be reported to your doctor.
• Remember that yellow Cialis should be used responsibly and as prescribed.
• The yellow Cialis pill is effective when combined with proper lifestyle changes.
• Men should avoid excessive doses to prevent complications.
• Yellow Cialis has become a standard treatment for ED in many countries.

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. · 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.

• The yellow Cialis pill is a popular choice due to its reliability and effectiveness.
• It is essential to get proper medical evaluation before starting yellow Cialis.
• The brand's distinctive yellow color supports easy identification and safety.
• Yellow Cialis should be stored away from moisture and heat.
• The pill’s design includes specific markings for safety during manufacturing.
• Duration of effectiveness makes yellow Cialis suitable for planned or spontaneous use.
• Avoid taking yellow Cialis with certain real or herbal supplements without consultation.
• The yellow Cialis pill helps improve self-confidence in men with ED.
• Always use yellow Cialis under the guidance of a healthcare professional.
• The pill’s pharmacokinetics allows for up to 36 hours of efficacy.
• Be aware of possible side effects such as nasal congestion and muscle aches.
• Proper use of yellow Cialis can significantly improve quality of life.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Cialis Food Interactions

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. Improves erectile function compared to placebo up to 36 hours post dose.

What should I tell my healthcare provider before using tadalafil?

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. 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).

Do not use CIALIS if:

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. (2.7, 5.6, 7.1, 12.2) (5)· Patients should seek emergency treatment if an erection lasts >4 hours. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction1.2 Benign Prostatic Hyperplasia1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia1.4 Limitation of Use2 DOSAGE AND ADMINISTRATION2.1 Tadalafil Tablets for Use as Needed for Erectile Dysfunction2.2 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction2.3 Tadalafil Tablet for Once Daily Use for Benign Prostatic Hyperplasia2.4 Tadalafil Tablet for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia2.5 Use with Food2.6 Use in Specific Populations2.7 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily Use5.3 Prolonged Erection5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-blockers and Antihypertensives5.7 Renal Impairment5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases5.14 Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Tadalafil Tablets7.2 Potential for Other Drugs to Affect Tadalafil Tablets7.3 Potential for Tadalafil Tablets to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil Tablets for Use as Needed for ED14.2 Tadalafil Tablet for Once Daily Use for ED14.3 Tadalafil Tablet 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)14.4 Tadalafil Tablet 5 mg for Once Daily Use for ED and BPH16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Guanylate Cyclase (GC) Stimulators17.3 Cardiovascular Considerations17.4 Concomitant Use with Drugs Which Lower Blood Pressure17.5 Potential for Drug Interactions When Taking Tadalafil Tablet for Once Daily Use17.6 Priapism17.7 Sudden Loss of Vision17.8 Sudden Hearing Loss17.9 Alcohol17.10 Sexually Transmitted Disease17.11 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed.

8.4 Pediatric Use

(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. (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. (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) (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). Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates (4.1).