ACYDONE- aluminum hydroxide, magnesium hydroxide, simethicone liquid

Acydone by

Drug Labeling and Warnings

Acydone by is a Otc medication manufactured, distributed, or labeled by Sigma, INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Warning

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.

Pregnant/Breastfeeding

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

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.

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Interior leaflet

INGREDIENTS AND APPEARANCE

ACYDONE 
aluminum hydroxide, magnesium hydroxide, simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84831-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	25 mg  in 5000 mg
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg  in 5000 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)	1 mg  in 5000 mg
MINT (UNII: FV98Z8GITP)	0.25 mg  in 5000 mg
ALCOHOL (UNII: 3K9958V90M)	40 mg  in 5000 mg
WATER (UNII: 059QF0KO0R)	3558.3 mg  in 5000 mg
CHERRY (UNII: BUC5I9595W)	2.5 mg  in 5000 mg
GLYCERIN (UNII: PDC6A3C0OX)	500 mg  in 5000 mg
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.45 mg  in 5000 mg
METHYLPARABEN (UNII: A2I8C7HI9T)	5 mg  in 5000 mg
XANTHAN GUM (UNII: TTV12P4NEE)	17.5 mg  in 5000 mg
SORBITOL (UNII: 506T60A25R)	400 mg  in 5000 mg
SODIUM SACCHARIN (UNII: SB8ZUX40TY)	50 mg  in 5000 mg

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHERRY, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84831-005-01	5000 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/11/2024

Labeler - Sigma (815366311)

Establishment
Name	Address	ID/FEI	Business Operations
INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.		815366311	manufacture(84831-005)