DEXANTA Chewable tablet Ref.[115624] Active ingredients: Aluminium hydroxide Magnesium hydroxide Simethicone

Source: Registered Drug Product Database (NG)  Revision Year: 2023  Publisher: Applicant / Holder of Certificate of Product Registration: Glorious Dexa Mandaya Ltd., 2nd Floor NIS Building, Plot B, Block H, Elephant Cement Way, Central Business District (CBD), Ikeja, Lagos, Nigeria Manufactured by: PT Beta Pharmacon, Kawasan Industri Suryacipta, Jl. Surya Madya Kav I-18C, Karawang-Indonesia For: PT Dexa Medica, Jl. Jend. Bambang Utoyo No. 138, Palembang-Indonesia

Product name and form

1.1 Product Name

DEXANTA.

1.2 Strength

Each chewable tablet contains:

Aluminium hydroxide dried gel equivalent to aluminium hydroxide 200 mg
Magnesium hydroxide 200 mg
Simethicone 50 mg

1.3 Pharmaceutical Dosage Form

Chewable tablet.

Pharmaceutical Form

Chewable tablet.

Green, round and flat beveled edge tablet, diameter 13 mm, peppermint odor, sweet astringent taste. Side I marked DEXA, side II with breakline.

Qualitative and quantitative composition

Aluminium hydroxide dried gel equivalent to aluminium hydroxide 200 mg
Magnesium hydroxide 200 mg
Simethicone 50 mg

Active Ingredient

Aluminium hydroxide is a slow-acting antacid. It is used to provide symptomatic relief in gastric hyperacidity. In addition, the antipeptic and demulcent activity of aluminium hydroxide helps to protect inflamed gastric mucosa against further irritation by gastric secretions.

Magnesium hydroxide is practically insoluble in water and solution is not effected until the hydroxide reacts with hydrochloric acid in the stomach to form magnesium chloride. Its neutralising action is almost equal to that of sodium bicarbonate. When the dose is in excess of that required to neutralise the acid the intragastric pH may reach pH 8 or 9. Acid rebound following magnesium hydroxide is clinically insignificant. Magnesium hydroxide has an indirect cathartic effect resulting from water retention in the intestinal lumen.

Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

List of Excipients

Lactose, corn/maize starch, methylparaben, propylparaben, sodium cyclamate, saccharin sodium, eurocert tartrazine, FD&C blue no. 1 powder, peppermint flavor, talc, magnesium stearate, purified water

Pack sizes and marketing

Box, 10 catch covers x 1 strip x 10 chewable tablets.

Marketing authorization holder

Applicant / Holder of Certificate of Product Registration:

Glorious Dexa Mandaya Ltd., 2nd Floor NIS Building, Plot B, Block H, Elephant Cement Way, Central Business District (CBD), Ikeja, Lagos, Nigeria

Manufactured by:

PT Beta Pharmacon, Kawasan Industri Suryacipta, Jl. Surya Madya Kav I-18C, Karawang-Indonesia

For:

PT Dexa Medica, Jl. Jend. Bambang Utoyo No. 138, Palembang-Indonesia

Drugs

Drug Countries
DEXANTA Nigeria

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