FDA.reportPublic FDA data

Aluminum Hydroxide

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:23:38

Label at a glance#

ProductAluminum Hydroxide
Active ingredientALUMINUM HYDROXIDE
Label structure8 sections

Indications and uses

relieves heartburn acid indigestion sour stomach

Dosage and administration

• shake well before using • do not take more than 12 teaspoonfuls in 24 hours • do not use the maximum dosage for more than 2 weeks • 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed dosage:

Storage and handling

• store at room temperature • protect from freezing  • keep tightly closed • TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 320 mg

Purpose

OTC - PURPOSE SECTION

Antacid


Uses

INDICATIONS & USAGE SECTION

relieves


  • heartburn
  • acid indigestion
  • sour stomach

Warnings

WARNINGS SECTION

taking a prescription drug. Antacids may interact with certain prescription drugs. you may get constipated symptoms last more than 2 weeks

Ask a doctor or pharmacist before use if you are



When using this product



Stop use and ask a doctor if


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before using • do not take more than 12 teaspoonfuls in 24 hours • do not use the maximum dosage for more than 2 weeks • 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed




dosage:


Other information

STORAGE AND HANDLING SECTION

• store at room temperature • protect from freezing  • keep tightly closed •


TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, flavor, glycerin, hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call 9am - 5pm EST, Monday-Friday 1-800-509-7592

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

ALUMINUM HYDROXIDE LIQUID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN7
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD7
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00317856009133(21)XXXXXXXXXXX(10)XXXXXXXXXX(17)010101GTIN-14: 00317856009133
GTIN-12: 317856009133
UPC-A: 317856009133
EAN-13: 0317856009133
GTIN storage (14 digits): 00317856009133		17856-0091-03 Rev. 2 Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0091-32024-04-16C16284748780-1f386c649-ab6b-0266-e053-dadaa90a7c1a60a54d4e-89c2-4329-86bf-a288527f37b5
17856-0091-32023-01-30C16284748780-1f386c649-ab6b-0266-e053-dadaa90a7c1a60a54d4e-89c2-4329-86bf-a288527f37b5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0091-3Aluminum Hydroxide30 mL in 1 CUPLIQUID307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0091-3ML - Milliliter17856-0091f51e697f-15bd-42dc-a54e-21759b65d2f412020-04-20
0536-0091-85ML - Milliliter0536-0091afd883fa-768d-4748-b1db-49ebdc5a3c1412013-02-13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-009117856-0091-3
0536-0091

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aluminum HydroxideALUMINUM HYDROXIDEATLANTIC BIOLOGICALS CORP.60a54d4e-89c2-4329-86bf-a288527f37b52025-12-15WarningsExact identifier
ndc (package): 17856-0091-3
ndc (product): 17856-0091
ndc11 (package): 17856009103
spl id: 4602216a-bb8c-af52-e063-6294a90a380e
spl set id: 60a54d4e-89c2-4329-86bf-a288527f37b5
Aluminum HydroxideALUMINUM HYDROXIDERugby Laboratories27c574a5-1fe0-4973-9a31-9beb4fc6ec462025-12-11WarningsExact identifier
ndc (product): 0536-0091

Reported adverse events (FAERS/openFDA)#

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