Acydone

Manufacturer
Sigma | INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.
Effective date
2024-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:36:46

Label at a glance#

ProductAcydone
Active ingredientDIMETHICONE, ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE
Label structure10 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION


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

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION


Use For The Following:

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

Warning

WARNINGS SECTION

Ask a Doctor if you have:

OTC - ASK DOCTOR SECTION

Ask a Doctor if you have:

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

Ask a doctor or pharmacist:

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Pregnant/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

RECENT MAJOR CHANGES SECTION

changed the title to indications and usage instead of directions.
Added the dosage and administrations sections.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label FrontLabel Front

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box FullBox Full

Interior leaflet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Interior leafletInterior leaflet

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
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9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84831-005-01Acydone5000 mg in 1 BOTTLELIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84831-005ACYDONE (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [SIGMA]11 package rows20241114_25e275cb-a13b-114a-e063-6394a90aa6ad.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84831-00584831-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25e275cb-a13c-114a-e063-6394a90aa6ad25e275cb-a13b-114a-e063-6394a90aa6ad2024-11-01WarningsExact identifier
spl id: 25e275cb-a13c-114a-e063-6394a90aa6ad
spl set id: 25e275cb-a13b-114a-e063-6394a90aa6ad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.