3 months to expiry Ghana · FDA Ghana

MASON NATURAL PROSTATE THERAPY COMPLEX SOFTGEL CAPSULES

saw palmetto, lycopene, beta-sitosterol, vitamin e

FDA/SD.233-060577 INN generic

What it does

Beta-sitosterol is a natural substance found in plants that may help manage cholesterol levels and support prostate health.

Commonly used for: high cholesterol (hyperlipidemia), enlarged prostate (benign prostatic hyperplasia)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.233-060577
Registration date
2023-06-07
Expiry date
2026-07-01
Status
3 months to expiry
Active ingredient
saw palmetto, lycopene, beta-sitosterol, vitamin e
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
47070
Manufacturer / MAH
Masons Vitamins
Applicant / LTR
BOTANICAL BENEFITS LTD
Country of origin
-
Manufacturer location
15750 NW 59th Ave, Hialeah, FL 33014, USA

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:59 · updated 2026-06-30 04:00:24

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About beta-sitosterol

Beta-sitosterol is a natural substance found in plants that may help manage cholesterol levels and support prostate health.

What it treats

  • high cholesterol (hyperlipidemia)
  • enlarged prostate (benign prostatic hyperplasia)

How it works

Beta-sitosterol helps reduce cholesterol absorption in the intestines and may improve urinary symptoms related to an enlarged prostate.

Who it's for

Adults looking to manage cholesterol or support prostate health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About lycopene

Lycopene is a natural pigment found in tomatoes and other red fruits and vegetables. It is known for its antioxidant properties.

What it treats

  • prostate cancer
  • breast cancer
  • heart disease
  • high cholesterol

How it works

Lycopene helps protect cells from damage caused by free radicals, which can contribute to various diseases.

Who it's for

Adults looking for potential health benefits related to cancer and heart health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About palmetto

Palmetto is a natural supplement often used for health issues related to the prostate.

What it treats

  • benign prostatic hyperplasia (BPH)
  • prostate health

How it works

Palmetto is believed to support prostate health by reducing symptoms associated with an enlarged prostate.

Who it's for

Palmetto is typically used by men, especially older adults, who are experiencing urinary symptoms due to prostate issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About saw

Saw is a herbal supplement often used for various health purposes.

What it treats

  • benign prostatic hyperplasia (BPH)
  • hair loss
  • prostate health

How it works

Saw is believed to work by affecting hormone levels and reducing inflammation.

Who it's for

Adults looking for support with prostate health or hair loss.

Cautions

  • • Consult a healthcare professional before use, especially if you are pregnant, breastfeeding, or have other medical conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About tocopherol

Tocopherol is a form of vitamin E, an antioxidant that helps protect cells from damage.

What it treats

  • skin health
  • antioxidant support
  • nutritional supplement

How it works

It helps protect your body from harmful substances by neutralizing free radicals.

Who it's for

It is suitable for people looking to support their overall health and skin condition.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: betasitosterol

BNF-referenced

Beta-sitosterol is a phytosterol, a plant-derived compound with a molecular formula of C29H50O. It is primarily found in various plant oils, nuts, seeds, and vegetables. Beta-sitosterol is known for its cholesterol-lowering properties and is often used as a dietary supplement to support cardiovascular health and manage benign prostatic hyperplasia (BPH). It works by competing with cholesterol for absorption in the intestines, thus reducing overall cholesterol levels in the body.

Indications

  • Hyperlipidemia
  • Benign prostatic hyperplasia (BPH)
  • Cholesterol management

Dosage

Children: Refer to BNF for Children for specific paediatric dosing information.

Adults: Refer to BNF for specific dosing recommendations, as they may vary based on the condition being treated and formulation used.

Mechanism of action

Beta-sitosterol exerts its effects by inhibiting the absorption of cholesterol in the intestines. It competes with cholesterol for intestinal uptake, leading to decreased levels of serum cholesterol. Additionally, it may influence the metabolism of steroids and other lipids through pathways involved in steroid biosynthesis and degradation, as evidenced by its association with the plant sterol biosynthesis pathway.

Pharmacodynamics

Beta-sitosterol is absorbed in the gastrointestinal tract and may lead to a slight reduction in serum cholesterol levels. Its phytosterolic structure allows it to mimic cholesterol, which aids in its absorption competitive action. Furthermore, it may have anti-inflammatory properties, which can contribute to its therapeutic effects in conditions like BPH and cholesterol management.

Pharmacokinetics

Beta-sitosterol is absorbed from the gastrointestinal tract, but its bioavailability is relatively low due to its poor solubility. The compound is metabolized in the liver and excreted in bile and urine. Its half-life and excretion details may vary based on individual metabolic processes.

Pregnancy

There is insufficient data on the use of betasitosterol during pregnancy. It is advised to consult healthcare professionals before use.

Breast-feeding

Limited data is available regarding the use of betasitosterol during breastfeeding. Caution is recommended, and consulting with a healthcare provider is advisable.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: lycopene

BNF-referenced

Lycopene is a naturally occurring carotenoid found predominantly in tomatoes and other red fruits. It is known for its potent antioxidant properties and its potential role in reducing the risk of certain cancers, particularly lung and prostate cancers. Lycopene has garnered attention for its ability to interfere with cancer cell growth and proliferation through various cellular mechanisms.

Indications

  • Dietary supplement for antioxidant support
  • Potential risk reduction for prostate cancer
  • Potential risk reduction for lung cancer

Dosage

Children: Refer to specific guidelines as dosing can vary based on the formulation and purpose of use.

Adults: Refer to specific guidelines as dosing can vary based on the formulation and purpose of use.

Mechanism of action

Lycopene functions as a very potent antioxidant, trapping singlet oxygen and reducing mutagenesis. It inhibits cancer cell growth by disrupting growth factor receptor signaling and cell cycle progression. Lycopene upregulates connexin 43, enhancing gap junctional communication which is often deficient in tumors. Furthermore, it exhibits synergistic effects on cell proliferation and differentiation when combined with 1,25-dihydroxyvitamin D3, indicating interactions at a nuclear or subcellular level.

Pharmacodynamics

Lycopene's antioxidant properties play a critical role in protecting cells from oxidative stress. By trapping reactive oxygen species, it lessens cellular damage and may help to prevent the initiation and progression of cancer. Its ability to modulate cell signaling pathways and improve gap junction communication contributes to its anticancer effects. The interactions with vitamin D3 suggest a complex role in regulating cellular functions.

Pharmacokinetics

Lycopene is absorbed in the intestine and can be detected in the serum and various tissues. Its bioavailability can be influenced by dietary factors, including fat intake, which enhances absorption. Once in the body, lycopene is stored in adipose tissue and the liver. The elimination half-life and exact metabolic pathways are not well defined, but it is believed to undergo some conversion into other metabolites before excretion.

Pregnancy

There is insufficient reliable information regarding the safety of lycopene during pregnancy. Caution is advised.

Breast-feeding

Lycopene is considered safe during breastfeeding, but data on its excretion in human milk is limited.

Storage

Store in a cool, dry place, away from light.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: palmetto

Palmetto, commonly known as saw palmetto, is derived from the fruit of the Serenoa repens plant. It is often used as a herbal supplement, primarily for its potential benefits in managing benign prostatic hyperplasia (BPH) and other urinary tract symptoms in men. In addition to its urological applications, saw palmetto may have roles in hormone regulation and potentially in hair loss treatments.

Indications

  • Benign prostatic hyperplasia (BPH)
  • Urinary tract symptoms related to prostate enlargement
  • Potentially for androgenic alopecia (hair loss)

Dosage

Children: Not established; use in children should be approached cautiously and under medical supervision.

Adults: Refer to specific product guidelines as dosing can vary widely depending on formulation and concentration.

Mechanism of action

Saw palmetto is believed to work by inhibiting the conversion of testosterone to dihydrotestosterone (DHT) via the action of 5-alpha reductase. This inhibition may reduce the size of the prostate and alleviate associated symptoms. Additionally, it may exert anti-inflammatory effects, which could further benefit urinary tract health.

Pharmacodynamics

The pharmacodynamic effects of saw palmetto include the modulation of androgenic activity and a reduction in prostatic cell proliferation. It may also have a mild diuretic effect, promoting urine flow. Saw palmetto can affect hormone levels, potentially impacting testosterone and estrogen metabolism.

Pharmacokinetics

Palmetto is typically administered orally, and its bioavailability can be influenced by factors such as formulation and meal composition. The active compounds are thought to be absorbed in the gastrointestinal tract. Saw palmetto is metabolized by the liver and excreted primarily through the urine, although specific pharmacokinetic parameters such as half-life and clearance rates are not well-established.

Adverse effects

  • Gastrointestinal disturbances
  • Headache
  • Dizziness
  • Allergic reactions
  • Sexual dysfunction

Interactions

  • May interact with anticoagulants, increasing the risk of bleeding
  • Can potentially affect the metabolism of drugs processed by the liver

Precautions

  • Use with caution in patients with hormone-sensitive conditions
  • Monitor for side effects in patients on concurrent medications

Pregnancy

Safety during pregnancy has not been established; use is generally not recommended.

Breast-feeding

Not enough is known about the safety of palmetto during breastfeeding; caution is advised.

Storage

Store in a cool, dry place away from light, and keep out of reach of children.

Formulations

  • Capsules
  • Tablets
  • Liquid extracts

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: tocopherol

BNF-referenced

Tocopherol, commonly known as vitamin E, is a fat-soluble antioxidant that plays a critical role in protecting cell membranes from oxidative stress. It is primarily found in various dietary sources, including nuts, seeds, and green leafy vegetables. Tocopherol acts by donating hydrogen atoms to free radicals, thereby neutralizing their harmful effects and preventing cellular damage.

Indications

  • Prevention of vitamin E deficiency
  • Antioxidant therapy
  • Support in conditions related to oxidative stress

Dosage

Children: Refer to BNF for Children for specific dosage guidelines.

Adults: Refer to BNF for specific dosage guidelines.

Mechanism of action

Tocopherol acts as a radical scavenger, primarily functioning as an antioxidant for lipid bilayers. It donates hydrogen atoms to free radicals, trapping them and preventing cellular damage. Its effectiveness is influenced by its location within the membrane and its interaction with cytosolic reductants like ascorbate. Tocopherol can trap multiple radicals, including alkyl and peroxy radicals.

Pharmacodynamics

The antioxidant properties of tocopherol lead to significant pharmacodynamic effects, including the inhibition of cell death through modulation of protein kinase C (PKC). Tocopherol also exhibits anti-inflammatory effects, which can be attributed to its influence on cytokines, prostaglandins, prostanoids, and thromboxanes. These interactions may contribute to its protective effects in various pathological conditions.

Pharmacokinetics

Tocopherol is absorbed in the intestines and its bioavailability can be influenced by dietary fat intake. It is transported in the plasma primarily bound to lipoproteins. Tocopherol is stored in adipose tissue and the liver, and its elimination occurs through bile and urine. The half-life of tocopherol can vary depending on the individual's nutritional status and other factors.

Pregnancy

Tocopherol is generally considered safe during pregnancy, but it is advisable to consult a healthcare provider before use.

Breast-feeding

Tocopherol is excreted in breast milk, and while it is considered safe, a healthcare provider should be consulted for specific recommendations.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: lycopene

PubChem CID 446925

Molecular formula: C40H56

Mechanism of action

Serum and tissue lycopene levels have been inversely related to the risk of lung and prostate cancers. Lycopene functions as a very potent antioxidant, and it can trap singlet oxygen and reduce mutagenesis in the Ames test. Lycopene at physiological concentrations can inhibit human cancer cell growth by interfering with growth factor receptor signaling and cell cycle progression. Studies using human and animal cells identified connexin 43, a gene whose expression is upregulated by lycopene and which allows direct intercellular gap junctional communication (GJC). GJC is deficient in many human tumors and its restoration or upregulation is associated with decreased proliferation. The combination of low concentrations of lycopene with 1,25-dihydroxyvitamin D3 exhibits a synergistic effect on cell proliferation and differentiation, and an additive effect on cell cycle progression in the HL-60 promyelocytic leukemia cell line, suggesting some interaction at a nuclear or subcellular level.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: tocopherol

PubChem CID 14986

Molecular formula: C28H48O2

Mechanism of action

Tocopherol acts as a radical scavenger. It mainly acts as an antioxidant for lipid bilayers. Tocopherol's functions depend on the H-atom donating ability, location, and movement within the membrane, as well as the efficiency in the radical recycling by some cytosolic reductants such as ascorbate. Tocopherol actions are related to the trap of radicals, and it has been shown that even in the absence of substituents in the ortho-positions, tocopherol can trap more than two radicals. The type of radicals available for tocopherol are alkyl and peroxy.

Pharmacodynamics

The antioxidant effects of tocopherol can be translated into different changes at the pharmacodynamic level. In vitro studies have shown that this antioxidant activity can produce modification in protein kinase C (PKC) which will later be translated into an inhibition of cell death. Some other derivate effects are the anti-inflammatory properties of tocopherol which can be related to the modulation of cytokines or prostaglandins, prostanoids and thromboxanes.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

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The same active ingredient registered across other registries we cover - including different brands.