25e275cb-a13b-114a-e063-6394a90aa6ad

SPL v1

SPL

SPL Set ID 25e275cb-a13b-114a-e063-6394a90aa6ad

Route

oral

Published

Effective Date 2024-11-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (1 mg) aluminum hydroxide (0.25 mg) magnesium cation (40 mg)

Inactive Ingredients

propylparaben mint alcohol water cherry glycerin anhydrous citric acid methylparaben xanthan gum sorbitol sodium saccharin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

unapproved drug other active Since 2024-11-11

Indications and Usage

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.

Purpose

Use For The Following: Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas

Description

Active ingredient (In each 5 ML Teaspoonful) Purpose Aluminium Hydroxide 200 mg Antacid Magnesium Hydroxide 200 mg Antacid Simeticone 25 mg Anti-gas

Medication Information

Indications and Usage

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.

Purpose

Use For The Following:

Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas

Directions

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.

Other Information

Keep tightly closed *Protect from feezing * do not use after the expiration date *store less than 86 ° F * ask a doctor if symptoms persist

Inactive Ingredients

Sodium saccharin, Sorbitol 70%, Methylparaben, Propylparaben, flavor, Anhydrous citric acid, ethyl alcohol, Xanthan gum, Glycerine, purified water

Description

Active ingredient (In each 5 ML Teaspoonful) Purpose Aluminium Hydroxide 200 mg Antacid Magnesium Hydroxide 200 mg Antacid Simeticone 25 mg Anti-gas

Section 43683-2

changed the title to indications and usage instead of directions.

Added the dosage and administrations sections.

Section 51945-4

Children

keep out of reach of children

Interior Leaflet

Active Ingredient

Active ingredient (In each 5 ML Teaspoonful) Purpose

Aluminium Hydroxide 200 mg Antacid

Magnesium Hydroxide 200 mg Antacid

Simeticone 25 mg Anti-gas

Pregnant/breastfeeding

If pregnant or breast-feeding. Ask a health professional before use.

Ask A Doctor If You Have:

Ask a Doctor if you have:

*kidney disease * a magnesium restricted diet * fever *vomiting * fructose intolerance

Ask A Doctor Or Pharmacist:

Ask a Doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs.

Structured Label Content

Indications and Usage

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.

Purpose

Use For The Following:

Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas

Directions

Other Information

Keep tightly closed *Protect from feezing * do not use after the expiration date *store less than 86 ° F * ask a doctor if symptoms persist

Inactive Ingredients

Sodium saccharin, Sorbitol 70%, Methylparaben, Propylparaben, flavor, Anhydrous citric acid, ethyl alcohol, Xanthan gum, Glycerine, purified water

Section 43683-2 (43683-2)

changed the title to indications and usage instead of directions.

Added the dosage and administrations sections.

Section 51945-4 (51945-4)

Children

keep out of reach of children

Interior Leaflet (Interior leaflet)

Active Ingredient

Active ingredient (In each 5 ML Teaspoonful) Purpose

Aluminium Hydroxide 200 mg Antacid

Magnesium Hydroxide 200 mg Antacid

Simeticone 25 mg Anti-gas

Pregnant/breastfeeding (Pregnant/Breastfeeding)

If pregnant or breast-feeding. Ask a health professional before use.

Ask A Doctor If You Have: (Ask a Doctor if you have:)

Ask a Doctor if you have:

*kidney disease * a magnesium restricted diet * fever *vomiting * fructose intolerance

Ask A Doctor Or Pharmacist: (Ask a doctor or pharmacist:)

Ask a Doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs.

Advanced Ingredient Data

[{"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "MINT", "unii": "FV98Z8GITP", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "40", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "3558.3", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CHERRY", "unii": "BUC5I9595W", "classCode": "IACT", "strengthNumerator": "2.5", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "500", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "0.45", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "17.5", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "400", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "50", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "5000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"43683-2": "changed the title to indications and usage instead of directions. Added the dosage and administrations sections.", "Purpose": "Use For The Following: Relief *Acid Indigestion *Heartburn * Sour Stomach * The Symptoms referred to as gas", "Children": "keep out of reach of children", "Directions": "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.", "Active Ingredient": "Active ingredient (In each 5 ML Teaspoonful) Purpose Aluminium Hydroxide 200 mg Antacid Magnesium Hydroxide 200 mg Antacid Simeticone 25 mg Anti-gas", "Other Information": "Keep tightly closed *Protect from feezing * do not use after the expiration date *store less than 86 ° F * ask a doctor if symptoms persist", "Inactive Ingredients": "Sodium saccharin, Sorbitol 70%, Methylparaben, Propylparaben, flavor, Anhydrous citric acid, ethyl alcohol, Xanthan gum, Glycerine, purified water", "Indications and Usage": "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.", "Pregnant/Breastfeeding": "If pregnant or breast-feeding. Ask a health professional before use.", "Ask a Doctor if you have:": "Ask a Doctor if you have: *kidney disease * a magnesium restricted diet * fever *vomiting * fructose intolerance", "Ask a doctor or pharmacist:": "Ask a Doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:22.698431 · Updated: 2026-03-14T23:05:04.083969