Gaviscon (Alginic Acid)

GAVISCON® Heartburn Relief Formula

SmithKline Beecham Consumer Healthcare

Alginic Acid Compound

Gastroesophageal Reflux Disease Therapy

Action And Clinical Pharmacology: The liquid or tablets, when chewed, produce a viscous, demulcent antacid foam which floats on the stomach contents, serving as a protective barrier for the esophagus against reflux of gastric contents. The alkaline foam readily flows up into the esophagus during reflux, aiding in the neutralization of refluxed gastric acids. Gaviscon also reduces the frequency of the reflux episodes.

Indications And Clinical Uses: The symptomatic treatment of heartburn and reflux esophagitis associated with gastric acid reflux (stomach acid reflux) and other causes.

Precautions: Each 5 mL of liquid contains approximately 30 mg of Naand each tablet contains approximately 22 mg of Na which should be noted for patients on severely restricted sodium diets.

The cations of magnesium and aluminum interfere with the absorption of tetracycline, iron and phosphate. In addition, oral magnesium may accumulate in the plasma of patients with impaired renal function, thus individuals with kidney ailments should consult a physician prior to taking this product.

Pregnancy: While no formal studies have been conducted to establish the safety of alginate compounds during pregnancy, there have been no reported adverse effects on fetal development.

Adverse Reactions: Nausea, vomiting, eructation, flatulence.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Should overdosage occur, gastric distention may result and is best treated conservatively.

Dosage And Administration: Regular Strength Tablets or Liquid: Adults: 2 to 4 tablets chewed thoroughly, or 10 to 20 mL of liquid after meals, at bedtime or as required. Maximum 16 tablets or 80 mL/day.

Extra Strength Tablets: Adults: 2 to 4 tablets chewed thoroughly, after meals, at bedtime or as required. Maximum 10 tablets/day.

Extra Strength Aluminum-Free Tablets: Adults: 2 to 4 tablets chewed thoroughly, after meals, at bedtime, or as required. Maximum 12 tablets/day.

Administration should be followed by a drink of water or milk. Do not swallow tablets whole.

Availability And Storage: Liquid: Each 5 mL of a light tan-colored, pleasantly fruit-flavored suspension or cream-colored, mint-flavored suspension contains: sodium alginate 250 mg and aluminum hydroxide 100 mg. Also contains parabens. Sodium: 1.3 mmol (30 mg). Alcohol-, gluten-, lactose-, sucrose- and tartrazine-free. No energy content. Plastic bottles of 50 (fruit only), 340 and 600 mL.

Tablets: Regular Strength (200 mg): Each round, creamy-white, butterscotch or fruit-flavored tablet, debossed “GAVISCON” on one side and “G” on the other, contains: alginic acid 200 mg and aluminum hydroxide 80 mg. Also contains sucrose 1.2 g. Energy: 20 kJ (4.7 kcal). Sodium:

Extra Strength (400 mg): Each round, creamy-white, butterscotch, fruit or strawberry-flavored tablet, debossed “GAVISCON” on one side and EXTRA on the other, contains: alginic acid 400 mg and aluminum hydroxide 160 mg. Also contains sucrose 1.8 g. Gluten-, lactose-, starch- and tartrazine-free. Plastic bottles of 25 and 60. Blister foil samples of 2 are also available.

Aluminum-Free: Regular Strength (200 mg): Each round, creamy-white, peppermint-flavored tablet contains: alginic acid 200 mg and magnesium carbonate 40 mg. Also contains sodium and sucrose. Bottles of 100.

Aluminum-Free: Extra Strength (313 mg): Each round, creamy-white, peppermint-flavored tablet contains: alginic acid 313 mg and magnesium carbonate 63 mg. Also contains sodium and sucrose. Bottles of 60.

GAVISCON® Heartburn Relief Formula SmithKline Beecham Consumer Healthcare Alginic Acid Compound Gastroesophageal Reflux Disease Therapy

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