FDA.reportPublic FDA data

HEARTBURN RELIEF

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION | GCP Laboratories
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:12

Label at a glance#

ProductHEARTBURN 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 SuspensionPSN2
245001aluminum hydroxide 50.8 MG/ML / magnesium carbonate 47.5 MG/ML Oral SuspensionSCD2
245001aluminum hydroxide 254 MG / magnesium carbonate 237.5 MG per 5 ML Oral SuspensionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-565-12HEARTBURN RELIEF355 mL in 1 BOTTLESUSPENSION3552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-565HEARTBURN RELIEF (ALUMINUM HYDROXIDE AND MAGNESIUM CARBONATE) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, Legacy NDC, 1 package rows20231107_b4656a2f-a866-5f7a-e053-2995a90ac2c2.zip

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
63868-56563868-565-12

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
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
DIMETHICONE92RU3N3Y1OIACT

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
HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONb4656a2f-a866-5f7a-e053-2995a90ac2c22023-11-06WarningsExact identifier
ndc (package): 63868-565-12
ndc (product): 63868-565
ndc11 (package): 63868056512
spl id: 097f7264-6848-61fb-e063-6294a90a3f2f
spl set id: b4656a2f-a866-5f7a-e053-2995a90ac2c2

Reported adverse events (FAERS/openFDA)#

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