International reference: 6 US FDA recalls for this ingredient

CGMP Deviations: Intermittent exposure to temperature excursion during storage. (dietary)

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. (dietary)

Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil (dietary)

Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein (dietary)

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. (dietary)

Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug. (dietary)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Ghana.

3 months to expiry Ghana · FDA Ghana

MEGA FIBER SACHETS ( dietary fiber/Inulin 4.35g/ 2.5g)

dietary fiber/Inulin

FDA/SD.233-060547 dietary fiber/Inulin 4.35g/ 2.5g INN generic

What it does

Dietary refers to substances that are consumed as part of food or supplements to support health and nutrition.

Commonly used for: nutritional support, weight management, vitamin and mineral supplementation

Read more in plain English ↓

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

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Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.233-060547
Registration date
2023-06-02
Expiry date
2026-07-01
Status
3 months to expiry
Active ingredient
dietary fiber/Inulin
Dosage form
dietary fiber/Inulin
Strength
4.35g/ 2.5g
Pack size
-
Therapeutic class
-
RxNorm RxCUI
70727
Country of origin
THAILAND
Manufacturer location
515, 1 Soi 8 D, Tambon Phraeksa, Amphoe Mueang Samut Prakan, Chang Wat Samut Prakan 10280, Thailand

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:00 · updated 2026-06-30 04:00:15

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

About dietary

Dietary refers to substances that are consumed as part of food or supplements to support health and nutrition.

What it treats

  • nutritional support
  • weight management
  • vitamin and mineral supplementation

How it works

Dietary substances provide essential nutrients that the body needs to function properly.

Who it's for

Anyone looking to improve their health, manage their weight, or supplement their diet.

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

About fiber

Fiber is a natural substance that helps support digestion and maintain a healthy bowel.

What it treats

  • constipation
  • irritable bowel syndrome (IBS)
  • diabetes management
  • heart health

How it works

Fiber adds bulk to the stool, making it easier to pass and helps regulate blood sugar levels.

Who it's for

Fiber is suitable for adults and children who need to improve their digestive health.

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

About inulin

Inulin is a type of fiber found in certain plants that helps improve digestive health and manage blood sugar levels.

What it treats

  • high blood sugar (hyperglycemia)
  • digestive issues
  • weight management

How it works

Inulin works by promoting the growth of good bacteria in the gut and can help slow down sugar absorption in the blood.

Who it's for

Inulin is suitable for people looking to improve their digestive health or manage their blood sugar levels.

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

Clinical monograph: dietary

Dietary refers to substances ingested for nutritional purposes, encompassing a wide range of foods and dietary supplements that provide essential nutrients such as carbohydrates, proteins, fats, vitamins, and minerals. It plays a crucial role in maintaining health, supporting growth and development, and preventing diseases. Proper dietary intake is essential for achieving optimal health outcomes.

Indications

  • Nutritional deficiency
  • Weight management
  • Support for chronic diseases
  • Improvement of overall health
  • Enhancement of athletic performance

Dosage

Children: Dietary recommendations for children vary based on age, growth rate, and developmental needs. It is advised to consult pediatric dietary guidelines to ensure appropriate nutrition.

Adults: Dietary intake should be tailored to individual needs based on age, sex, activity level, and health status. General guidelines suggest a balanced diet comprising fruits, vegetables, whole grains, lean proteins, and healthy fats.

Mechanism of action

Dietary substances work through various mechanisms depending on their composition. Macronutrients like carbohydrates, proteins, and fats provide energy and building blocks for cellular processes. Micronutrients, including vitamins and minerals, are involved in enzymatic reactions, hormone production, and maintaining physiological balance. For example, vitamin D aids in calcium absorption, while omega-3 fatty acids play a role in anti-inflammatory pathways.

Pharmacodynamics

The pharmacodynamics of dietary components is complex, as they interact with numerous biological pathways and systems. Macronutrients influence metabolic pathways, while micronutrients are crucial for enzymatic functions. For instance, antioxidants found in fruits and vegetables help mitigate oxidative stress, and dietary fiber supports gut health and regulates blood sugar levels. The balance and composition of dietary intake can significantly influence body weight, immune response, and overall metabolism.

Pharmacokinetics

The pharmacokinetics of dietary substances varies widely. Nutrients are absorbed in the gastrointestinal tract, with macronutrients primarily absorbed in the small intestine. The bioavailability of certain vitamins and minerals can be affected by factors such as food matrix, presence of other nutrients, and individual digestive health. After absorption, nutrients enter the bloodstream, distributing to tissues where they exert their effects. Excess amounts may be stored (e.g., fat-soluble vitamins) or excreted (e.g., water-soluble vitamins).

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: fiber

Fiber, also known as dietary fiber, refers to plant-based carbohydrates that cannot be digested by human enzymes. It includes soluble and insoluble types, both of which play essential roles in maintaining digestive health, regulating blood sugar levels, and aiding in weight management. Common sources of dietary fiber include fruits, vegetables, whole grains, legumes, and nuts.

Indications

  • Constipation
  • Irritable bowel syndrome (IBS)
  • Diverticulitis
  • Hyperlipidemia
  • Type 2 diabetes management
  • Weight management

Dosage

Children: For children, the recommended daily intake of fiber varies by age and is approximately 14 grams per 1,000 calories consumed. It is advisable to refer to specific pediatric guidelines for more detailed dosing.

Adults: The general recommendation for adults is to consume 25 to 30 grams of dietary fiber daily from food sources, rather than supplements, to promote optimal health.

Mechanism of action

Fiber works primarily by adding bulk to the stool and facilitating regular bowel movements. Soluble fiber dissolves in water to form a gel-like substance, which can help to slow digestion and regulate blood sugar levels by slowing the absorption of sugar. Insoluble fiber does not dissolve in water and helps food pass more quickly through the stomach and intestines.

Pharmacodynamics

The pharmacodynamics of fiber involve its ability to enhance gastrointestinal health. Soluble fiber can lower cholesterol levels, improve glycemic control, and promote satiety, which may assist in weight management. Insoluble fiber contributes to increased stool bulk and can help prevent constipation. The fermentation of soluble fiber in the colon produces short-chain fatty acids, which have various health benefits, including anti-inflammatory effects.

Pharmacokinetics

Fiber is not absorbed in the gastrointestinal tract; thus, it has no bioavailability. It passes through the stomach and small intestine largely intact, reaching the colon where it can be fermented by gut microbiota. The rate of fermentation and the production of short-chain fatty acids can vary based on the type of fiber consumed and the individual's gut microbiome.

Adverse effects

  • Bloating
  • Gas
  • Abdominal cramps
  • Diarrhea
  • Constipation

Precautions

  • Increase fiber intake gradually to avoid gastrointestinal discomfort.
  • Adequate fluid intake is necessary to prevent constipation.
  • Caution is advised in patients with gastrointestinal disorders.

Pregnancy

Fiber is generally considered safe during pregnancy. It supports digestive health and can help alleviate constipation common in this population.

Breast-feeding

Fiber is safe during breastfeeding and can aid in postpartum digestive health.

Storage

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

Formulations

  • Powder
  • Capsules
  • Tablets
  • Granules
  • Natural food sources (fruits, vegetables, whole grains)

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: inulin

Inulin is a naturally occurring polysaccharide composed of fructose units, primarily extracted from chicory roots. It is classified as a soluble dietary fiber and is used therapeutically as an insulin sensitizer in the management of type 2 diabetes and for its prebiotic effects, promoting gut health. Inulin is not digested in the upper gastrointestinal tract, allowing it to reach the colon where it can be fermented by gut microbiota.

Indications

  • Type 2 diabetes mellitus
  • Hyperglycemia
  • Irritable bowel syndrome
  • Constipation
  • Dysbiosis

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing, as it is not universally established.

Adults: Refer to specific clinical guidelines and local protocols for appropriate dosing, as it may vary based on the condition being treated.

Mechanism of action

Inulin functions primarily as a prebiotic, stimulating the growth of beneficial gut bacteria and enhancing gut health. It may improve insulin sensitivity and glycemic control by modulating gut hormones, leading to increased secretion of glucagon-like peptide-1 (GLP-1), which enhances insulin secretion and decreases glucagon levels. Additionally, it may slow gastric emptying, contributing to a reduction in postprandial blood glucose levels.

Pharmacodynamics

Inulin's pharmacodynamics involve its role in carbohydrate metabolism and its effects on gut microbiota. By promoting the growth of beneficial bacteria, it can lead to improved intestinal barrier function and reduced inflammation. Inulin also aids in the modulation of lipid metabolism, potentially lowering cholesterol levels. Its effects on insulin sensitivity can help improve glycemic control in patients with insulin resistance.

Pharmacokinetics

Inulin is not absorbed in the gastrointestinal tract; it remains intact until it reaches the colon. It is fermented by intestinal bacteria, producing short-chain fatty acids (SCFAs) that may have systemic effects. The fermentation of inulin results in an increase in stool bulk and may improve bowel regularity. The time to reach the colon varies, but fermentation typically begins within 24 hours of ingestion. The elimination route is primarily through feces, as it is not metabolized by human enzymes.

Contra-indications

  • Hypoglycemia
  • Hypersensitivity to inulin or its components

Adverse effects

  • Hypoglycemia
  • Allergic reactions including rash, itching, or swelling
  • Gastrointestinal disturbances such as nausea, vomiting, or diarrhea
  • Injection site reactions

Interactions

  • Insulin and other antidiabetic agents may increase the risk of hypoglycemia
  • Certain medications like corticosteroids, diuretics, and thiazide diuretics may reduce the effectiveness of inulin

Precautions

  • Monitor blood glucose levels closely, especially when initiating therapy or adjusting doses
  • Caution in patients with renal impairment as clearance may be affected
  • Use with caution in patients with liver dysfunction

Pregnancy

Inulin is generally considered safe during pregnancy; however, blood glucose levels should be monitored closely.

Breast-feeding

Inulin is excreted in breast milk, but it is typically considered safe during breastfeeding; consult with a healthcare provider for individualized advice.

Storage

Store in a refrigerator (2-8°C). Do not freeze. Keep out of reach of children.

Formulations

  • Injectable forms (e.g., insulin syringes or pens)
  • Inhalable formulations (in some regions)

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

This drug in other countries

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