The following Structured Product Label (SPL) was submitted to the FDA by Sigma for the product Acydone (NDC 84831-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, indications and usage, purpose, ask a doctor if you have:, ask a doctor or pharmacist:, pregnant/breastfeeding, children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (In each 5 ML Teaspoonful) Purpose
Aluminium Hydroxide 200 mg Antacid
Magnesium Hydroxide 200 mg Antacid
Simeticone 25 mg Anti-gas
COMPOSITION Each 5 ml of Suspension contains:
Aluminum hydroxide………..…. 200 mg antacid
Magnesium Hydroxide ............. 200 mg antacid
Simethicone ………………….…. 25 mg antiflatulence
ACYDONE@ GEL is indicated in: Gastric hyperacidity of different origins, gastritis, esophagitis, flatulence, peptic ulcer, adjuvant in the treatment of gastroesophageal reflux, duodenitis, gastrointestinal disorders with excess gas.
Use For The Following:
Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas
Ask a Doctor if you have:
*kidney disease * a magnesium restricted diet * fever *vomiting * fructose intolerance
Ask a Doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs.
If pregnant or breast-feeding. Ask a health professional before use.
keep out of reach of children
Shake well before use * Adults and children 12 years of age and older: take 10 ml to 20 ml (2 to 4 teaspoonfuls) between meals, at bed time or as directed by a doctor * Do not take more than 24 teaspoonful in 24 hours. Take Orally.
Keep tightly closed *Protect from feezing * do not use after the expiration date *store less than 86 ° F * ask a doctor if symptoms persist
Sodium saccharin, Sorbitol 70%, Methylparaben, Propylparaben, flavor, Anhydrous citric acid, ethyl alcohol, Xanthan gum, Glycerine, purified water
changed the title to indications and usage instead of directions.
Added the dosage and administrations sections.
* Please review the disclaimer below.
