3 months to expiry Ghana · FDA Ghana

STERECOL NIGHT GUMMIES

MELATONIN/ASHWARGANDA/LEMON

FDA/SD.233-111309 MELATONIN/ASHWARGANDA/LEMON nervous system INN generic

What it does

Ashwagandha is a herbal supplement often used for its potential health benefits, including stress relief and improved energy.

Commonly used for: stress and anxiety, fatigue, general wellness

Read more in plain English ↓

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.233-111309
Registration date
2023-11-13
Expiry date
2026-12-01
Status
3 months to expiry
Active ingredient
MELATONIN/ASHWARGANDA/LEMON
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
N05CH - Melatonin receptor agonists
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
6711
Manufacturer / MAH
Alax Bio Research
Country of origin
-
Manufacturer location
PLOT NO.5, TIM ENGINEERING ESTATE, VASNA-CHACHERVADI ROAD, Moraiya, Changodar, Gujarat 382213, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:06 · updated 2026-09-18 04:00:04

Drug Interactions

13
Check interactions

Pharmacodynamic Warnings

Melatonin appears in TABLE 11: Drugs with CNS depressant effects

Severe (1)

Melatonin - increases exposure

Fluvoxamine very markedly increases the exposure to melatonin. Avoid.

Severe Study

Moderate (1)

Melatonin - increases exposure

Givosiran is predicted to increase the exposure to melatonin. Use with caution and adjust dose.

Moderate Study

Unknown (11)

Melatonin - decreases exposure

Phenytoinispredictedtodecreasetheexposuretomelatonin. oTheoretical

Unknown Theoretical

Melatonin - increases exposure

Axitinibispredictedtoincreasetheexposuretomelatonin. oTheoretical

Unknown Theoretical

Melatonin - decreases exposure

Ritonavirispredictedtodecreasetheexposuretomelatonin. oTheoretical

Unknown Theoretical

Melatonin - decreases exposure

Leflunomideispredictedtodecreasetheexposureto melatonin.oTheoretical

Unknown Theoretical

Melatonin - increases exposure

Mexiletineispredictedtoincreasetheexposuretomelatonin. oTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

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

About ashwarganda

Ashwagandha is a herbal supplement often used for its potential health benefits, including stress relief and improved energy.

What it treats

  • stress and anxiety
  • fatigue
  • general wellness

How it works

Ashwagandha is believed to help the body adapt to stress and support overall health by balancing hormones and reducing inflammation.

Who it's for

Adults looking for natural ways to manage stress and improve their well-being.

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

About lemon

Lemon is a citrus fruit known for its tangy flavor and potential health benefits.

What it treats

  • vitamin C deficiency (scurvy)
  • boosting the immune system
  • aiding digestion
  • skin health

How it works

Lemon is rich in vitamin C and antioxidants, which help support the body's immune system and overall health.

Who it's for

Lemon can be enjoyed by most people as part of a balanced diet.

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

About melatonin

Melatonin is a natural hormone that helps regulate sleep patterns.

What it treats

  • insomnia
  • jet lag
  • sleep disorders

How it works

Melatonin helps signal to your body that it's time to sleep, promoting a natural sleep cycle.

Who it's for

Adults and children who have trouble sleeping or adjusting to new sleep schedules.

Cautions

  • • Be careful if you are taking other medications that make you sleepy.

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

Clinical monograph: Melatonin

BNF-referenced

Adverse effects

  • Arthralgia
  • Infection
  • Dizziness
  • Dry mouth
  • Gastrointestinal discomfort
  • Headaches
  • Nausea
  • Altered mood
  • Night sweats
  • Skin reactions
  • Aggression
  • Depression
  • Disorientation
  • Weight gain
  • Electrolyte imbalance

Interactions

  • Fluvoxamine: Severe (increases exposure)
  • Givosiran: Moderate (increases exposure)
  • Phenytoin: Unknown (decreases exposure)
  • Axitinib: Unknown (increases exposure)
  • Ritonavir: Unknown (decreases exposure)
  • Leflunomide: Unknown (decreases exposure)
  • Mexiletine: Unknown (increases exposure)
  • Osilodrostat: Unknown (increases exposure)
  • Rucaparib: Unknown (increases exposure)
  • Teriflunomide: Unknown (decreases exposure)

Precautions

  • Use with caution in hepatic impairment
  • Use with caution in renal impairment
  • Drowsiness may persist into the next day, affecting performance of skilled tasks such as driving

Pregnancy

No information available-avoid.

Breast-feeding

Present in milk-avoid.

Storage

Store in a cool, dry place away from light.

Formulations

  • Modified-release tablets (Circadin®, Slenyto®)
  • Immediate-release tablets (Adaflex®, Ceyesto®, Syncrodin®)
  • Hard capsules
  • Oral solution
BNF 85 (British National Formulary) p.548 BNF for Children 2019-2020 p.325 PubChem / pathway

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: ashwarganda

Ashwagandha, also known as Withania somnifera, is an adaptogenic herb commonly used in traditional Ayurvedic medicine. It is known for its potential to enhance resilience to stress, improve overall vitality, and promote mental clarity. Ashwagandha has been studied for its effects on anxiety, depression, and cognitive function, and is often used as a natural remedy for various health conditions.

Indications

  • Stress and anxiety management
  • Cognitive enhancement
  • Support for mood disorders
  • General vitality and wellness improvement
  • Adjuvant therapy in certain chronic conditions

Dosage

Children: There is limited research on the safety and efficacy of ashwagandha in children.

Adults: Dosage of ashwagandha varies widely depending on the formulation and purpose. Typical doses range from 300 mg to 600 mg of standardized extract daily, divided into two or three doses. It is advisable to consult healthcare professionals for specific dosing recommendations.

Mechanism of action

Ashwagandha acts through multiple mechanisms, including modulation of the hypothalamic-pituitary-adrenal (HPA) axis, reducing cortisol levels, and exerting antioxidant effects. It may enhance neurotransmitter function by increasing levels of serotonin and GABA, contributing to its anxiolytic and mood-stabilizing effects. Additionally, ashwagandha may influence the immune system and possess anti-inflammatory properties.

Pharmacodynamics

The pharmacodynamics of ashwagandha involve its ability to promote homeostasis in the body, particularly in response to stress. It can enhance physical performance, boost energy levels, and improve cognitive function. The herb's adaptogenic properties help to balance physiological processes and improve resilience against stressors. Overall, ashwagandha may improve mental health, promote relaxation, and support physical endurance.

Pharmacokinetics

Ashwagandha is typically administered as an extract or powder. After oral administration, it is absorbed in the gastrointestinal tract, with the active constituents, such as withanolides, exerting their effects systemically. The metabolism of ashwagandha is largely hepatic, and elimination occurs primarily through renal excretion. The onset of effects can vary, with some users experiencing benefits within a few days of consistent use, while others may take longer to notice significant changes.

Adverse effects

  • Gastrointestinal upset
  • Diarrhea
  • Nausea
  • Headaches
  • Drowsiness
  • Allergic reactions

Interactions

  • Sedatives and tranquilizers may have additive effects
  • Thyroid hormone medications may interact due to its potential thyroid-stimulating effects
  • Medications metabolized by the liver may interact due to potential effects on liver enzymes

Precautions

  • Should be used with caution in individuals with autoimmune diseases
  • Use with caution in patients with thyroid disorders
  • Consult healthcare provider before use in patients taking other medications or with underlying health conditions

Pregnancy

Limited data on safety during pregnancy, use with caution and consult a healthcare provider.

Breast-feeding

Limited data on safety during breastfeeding, consult a healthcare provider before use.

Storage

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

Formulations

  • Powder
  • Capsules
  • Tablets
  • Liquid extract

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: lemon

Lemon (Citrus limon) is a citrus fruit known for its high vitamin C content and antioxidant properties. It is widely used in culinary applications and traditional medicine. The fruit, juice, and peel are often utilized for their potential health benefits, including digestive aid, immune support, and skin health.

Indications

  • Scurvy prevention
  • Digestive aid
  • Immune system support
  • Skin health
  • Antimicrobial applications

Dosage

Children: There is no specific paediatric dosage for lemon; it can be given to children in moderate amounts as part of a balanced diet.

Adults: There is no specific adult dosage for lemon; it can be consumed in various forms such as fresh fruit, juice, or as part of food and beverages.

Mechanism of action

Lemon contains compounds such as citric acid, flavonoids, and essential oils. Citric acid may enhance the absorption of minerals and has a role in the Krebs cycle, promoting energy metabolism. Flavonoids possess antioxidant properties, which help combat oxidative stress and inflammation, while essential oils can exhibit antimicrobial and anti-inflammatory effects.

Pharmacodynamics

The pharmacodynamic effects of lemon are primarily attributed to its antioxidant properties, which help neutralize free radicals, reduce oxidative stress, and support overall health. The citric acid in lemon may also aid in alkalizing the body, improving metabolic processes, and supporting digestion.

Pharmacokinetics

The bioavailability of lemon compounds can vary based on the form of consumption (whole fruit, juice, or extract). Vitamin C is rapidly absorbed in the gastrointestinal tract and distributed throughout the body. The metabolism of flavonoids occurs primarily in the liver, and they may have a variable half-life depending on individual metabolism.

Adverse effects

  • Allergic reactions in sensitive individuals
  • Gastrointestinal discomfort
  • Tooth enamel erosion with excessive use

Precautions

  • Caution in individuals with citrus allergies
  • May cause skin irritation if applied topically in concentrated forms

Pregnancy

Lemon is generally considered safe during pregnancy, but excessive intake should be avoided.

Breast-feeding

Lemon is safe during breastfeeding when consumed in normal dietary amounts.

Storage

Store in a cool, dry place. Fresh lemons should be kept in the refrigerator to maintain freshness.

Formulations

  • Fresh lemon
  • Lemon juice
  • Lemon essential oil
  • Lemon zest

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: Melatonin

PubChem CID 896

Molecular formula: C13H16N2O2

Mechanism of action

Melatonin is a derivative of tryptophan. It binds to melatonin receptor type 1A, which then acts on adenylate cylcase and the inhibition of a cAMP signal transduction pathway. Melatonin not only inhibits adenylate cyclase, but it also activates phosphilpase C. This potentiates the release of arachidonate. By binding to melatonin receptors 1 and 2, the downstream signallling cascades have various effects in the body. The melatonin receptors are G protein-coupled receptors and are expressed in various tissues of the body. There are two subtypes of the receptor in humans, melatonin receptor 1 (MT1) and melatonin receptor 2 (MT2). Melatonin and melatonin receptor agonists, on market or in clinical trials, all bind to and activate both receptor types.The binding of the agonists to the receptors has been investigated for over two decades or since 1986. It is somewhat known, but still not fully understood. When melatonin receptor agonists bind to and activate their receptors it causes numerous physiological processes. MT1 receptors are expressed in many regions of the central nervous system (CNS): suprachiasmatic nucleus of the hypothalamus (SNC), hippocampus, substantia nigra, cerebellum, central dopaminergic pathways, ventral tegmental area and nucleus accumbens. MT1 is also expressed in the retina, ovary, testis, mammary gland, coronary circulation and aorta, gallbladder, liver, kidney, skin and the immune system. MT2 receptors are expressed mainly in the CNS, also in the lung, cardiac, coronary and aortic tissue, myometrium and granulosa cells, immune cells, duodenum and adipocytes. The binding of melatonin to melatonin receptors activates a few signaling pathways. MT1 receptor activation inhibits the adenylyl cyclase and its inhibition causes a rippling effect of non activation; starting with decreasing formation of cyclic adenosine monophosphate (cAMP), and then progressing to less protein kinase A (PKA) activity, which in turn hinders the phosphorilation of cAMP responsive element-binding protein (CREB binding protein) into P-CREB. MT1 receptors also activate phospholipase C (PLC), affect ion channels and regulate ion flux inside the cell. The binding of melatonin to MT2 receptors inhibits adenylyl cyclase which decreases the formation of cAMP.[4] As well it hinders guanylyl cyclase and therefore the forming of cyclic guanosine monophosphate (cGMP). Binding to MT2 receptors probably affects PLC which increases protein kinase C (PKC) activity. Activation of the receptor can lead to ion flux inside the cell. Melatonin is implicated in numerous physiological processes, including circadian rhythms, stress, and reproduction, many of which are mediated by the hypothalamus and pituitary. The physiological actions of melatonin are mainly mediated by melatonin receptors. /The authors/ describe the distribution of the melatonin receptor MT1 in the human hypothalamus and pituitary by immunocytochemistry. MT1 immunoreactivity showed a widespread pattern in the hypothalamus. In addition to the area of the suprachiasmatic nucleus (SCN), a number of novel sites, including the paraventricular nucleus (PVN), periventricular nucleus, supraoptic nucleus (SON), sexually dimorphic nucleus, the diagonal band of Broca, the nucleus basalis of Meynert, infundibular nucleus, ventromedial and dorsomedial nucleus, tuberomamillary nucleus, mamillary body, and paraventricular thalamic nucleus were observed to have neuronal MT1 receptor expression. No staining was observed in the nucleus tuberalis lateralis and bed nucleus of the stria terminalis. The MT1 receptor was colocalized with some vasopressin (AVP) neurons in the SCN, colocalized with some parvocellular and magnocellular AVP and oxytocine (OXT) neurons in the PVN and SON, and colocalized with some parvocellular corticotropin-releasing hormone (CRH) neurons in the PVN. In the pituitary, strong MT1 expression was observed in the pars tuberalis, while a weak staining was found in the posterior and ant

Pharmacodynamics

Melatonin is a hormone normally produced in the pineal gland and released into the blood. The essential amino acid L-tryptophan is a precursor in the synthesis of melatonin. It helps regulate sleep-wake cycles or the circadian rhythm. Production of melatonin is stimulated by darkness and inhibited by light. High levels of melatonin induce sleep and so consumption of the drug can be used to combat insomnia and jet lag. MT1 and MT2 receptors may be a target for the treatment of circadian and non circadian sleep disorders because of their differences in pharmacology and function within the SCN. SCN is responsible for maintaining the 24 hour cycle which regulates many different body functions ranging from sleep to immune functions

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.