FDA.reportPublic FDA data

Aluminum Hydroxide

Manufacturer
LLC Federal Solutions | Safecor Health, LLC
Effective date
2013-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:34

Label at a glance#

ProductAluminum Hydroxide
Active ingredientALUMINUM HYDROXIDE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL teaspoonful)
Aluminum hydroxide 320 mg

OTC - PURPOSE SECTION

Purpose
Antacid

INDICATIONS & USAGE SECTION

Uses
For the relief of

  • heartburn
  • acid indigestion
  • sour stomach

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product you may get constipated

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms last more than 2 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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
  • dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-855-333-6337

SPL UNCLASSIFIED SECTION

Repackaged by:
Safecor Health LLC
317 New Boston St.
Woburn, MA 01801
Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33123

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-091-30
ALUMINUM HYDROXIDE
GEL, USP
1920 mg / 30 mL
DELIVERS 30 mL
SUGAR FREE
MINT FLAVOR
SHAKE WELL BEFORE USING
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

product labelproduct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN1
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD1
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24451-091-302019-11-27C16284748780-19855d018-ed26-cd31-e053-dbdaa90ab51aaf9b799f-69c5-401c-9c43-a97b23384cc2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24451-091-30Aluminum Hydroxide30 mL in 1 CUP, UNIT-DOSEGEL301
24451-091-30Aluminum Hydroxide100 in 1 BOXGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24451-091ALUMINUM HYDROXIDE GEL [LLC FEDERAL SOLUTIONS]1Legacy NDC, 2 package rows20130816_af9b799f-69c5-401c-9c43-a97b23384cc2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0091-85ML - Milliliter0536-0091afd883fa-768d-4748-b1db-49ebdc5a3c1412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN01
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN01
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL451
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
24451-09124451-091-30
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
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUM DIHYDRATESB8ZUX40TYIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route
7 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii+dosage form
7 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+route
10 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45CAPSULE / ORAL2.98 mgExact identifier — unii+route
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii+route
7 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+dosage form
10 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii+route
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45TABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii+route
3 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii+route
7 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45SOLUTION / ORAL34 mgExact identifier — unii+route
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii+route
7 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8DROPS / ORALNAExact identifier — unii+route
10 equally ranked IID candidates

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 HYDROXIDERugby Laboratories27c574a5-1fe0-4973-9a31-9beb4fc6ec462025-12-11WarningsExact identifier
ndc (product): 0536-0091
18de8a4b-df09-498a-ab6b-df914a59e48aaf9b799f-69c5-401c-9c43-a97b23384cc22013-08-12WarningsExact identifier
spl id: 18de8a4b-df09-498a-ab6b-df914a59e48a
spl set id: af9b799f-69c5-401c-9c43-a97b23384cc2

Reported adverse events (FAERS/openFDA)#

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