FDA.reportPublic FDA data

EXTRA STRENGTH HEARTBURN RELIEF

Manufacturer
CARDINAL HEALTH | GCP Laboratories
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:19

Label at a glance#

ProductEXTRA STRENGTH HEARTBURN RELIEF
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM CARBONATE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion upset stomach associated with these symptoms

Dosage and administration

shake well before use adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor children under 12 years: consult a doctor take after meals and at bedtime dispense product only by spoon or other measuring device

Storage and handling

each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg store at room temperature protect from freezing keep tightly closed TAMPER-EVIDENT : Do not use this product if inner foil seal over mouth of the bottle is broken or missing.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 254 mg
Magnesium carbonate 237.5 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet
  • a sodium-restricted diet

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

  • laxative effect may occur
  • do not use maximum dosage for more than 2 weeks
  • do not take more than 16 teaspoonfuls in 24 hours

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.In case of overdose, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • adults and children 12 years and older take 2-4 teaspoonsful four times a day or as directed by a doctor
  • children under 12 years: consult a doctor
  • take after meals and at bedtime
  • dispense product only by spoon or other measuring device

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL teaspoonful contains: magnesium 70 mg, sodium 16 mg
  • store at room temperature
  • protect from freezing
  • keep tightly closed
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, edetate disodium, flavor, glycerin, purified water, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, xanthan gum

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
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG in 5 mL Oral SuspensionPSN4
245001aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral SuspensionSCD4
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG per 5 ML Oral SuspensionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0363-1EXTRA STRENGTH HEARTBURN RELIEF355 mL in 1 BOTTLESUSPENSION3554

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0363EXTRA STRENGTH HEARTBURN RELIEF (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) SUSPENSION [CARDINAL HEALTH]4Current NDC, Legacy NDC, 1 package rows20231108_7ee2f64b-9719-6aa0-e053-2991aa0aeb48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0363-1ML - Milliliter70000-036358cdf8d0-b2f6-4bc8-8499-e1892a91949912019-08-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-036370000-0363-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ALGINATEC269C4G2ZQIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
DIMETHICONE92RU3N3Y1OIACT

Source Document#

Source XML · Source PDF

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
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECARDINAL HEALTH7ee2f64b-9719-6aa0-e053-2991aa0aeb482023-11-07WarningsExact identifier
ndc (package): 70000-0363-1
ndc (product): 70000-0363
ndc11 (package): 70000036301
spl id: 0993a2d5-6d02-678d-e063-6394a90a2ac5
spl set id: 7ee2f64b-9719-6aa0-e053-2991aa0aeb48

Reported adverse events (FAERS/openFDA)#

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