FDA.reportPublic FDA data

Aluminum Hydroxide

Manufacturer
Rugby Laboratories | GCP Laboratories
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:23:09

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 dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed children under 12 years: ask a doctor

Storage and handling

store at room temperature protect from freezing keep tightly closed

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

Ask a doctor or pharmacist before use if you are taking a prescription drug.

Antacids may interact with certain prescription drugs.
When using this product you may get constipated

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

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

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
  • dosage: 2 teaspoonfuls 5-6 times daily after meals and at bedtime followed by a sip of water if needed
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

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

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308078aluminum hydroxide 320 MG in 5 mL Oral SuspensionPSN4
308078aluminum hydroxide 64 MG/ML Oral SuspensionSCD4
308078aluminum hydroxide 320 MG per 5 ML Oral SuspensionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-0091-85Aluminum Hydroxide473 mL in 1 BOTTLELIQUID4734

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 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-00910536-0091-85

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
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL SOLUTION8KW3E207O2IACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45TABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii+route
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route
20 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
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route
14 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
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8DROPS / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii+dosage form
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii+route
14 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45SOLUTION / ORAL34 mgExact identifier — unii+route
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+dosage form
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8DROPS / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii+route
14 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route
20 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45SOLUTION / ORAL34 mgExact identifier — unii+route
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii+route
14 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii+route
14 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii+route
14 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+route
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+dosage form
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii+route
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii+route
20 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
6 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii+route
20 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii+dosage form
14 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii+route
20 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aluminum HydroxideALUMINUM HYDROXIDERugby Laboratories27c574a5-1fe0-4973-9a31-9beb4fc6ec462025-12-11WarningsExact identifier
ndc (package): 0536-0091-85
ndc (product): 0536-0091
ndc11 (package): 00536009185
spl id: 45aff4ec-4b96-2833-e063-6394a90a2f26
spl set id: 27c574a5-1fe0-4973-9a31-9beb4fc6ec46

Reported adverse events (FAERS/openFDA)#

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