FDA.reportPublic FDA data

SUPREME ANTACID

Manufacturer
FAMILY DOLLAR SERVICES INC | GCP Laboratories
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:17:13

Label at a glance#

ProductSUPREME ANTACID
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion upset stomach associated with these symptoms overindulgence in food and drink

Dosage and administration

shake well before use adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor do not take more than 18 teaspoonfuls in a 24 hour period or use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor

Storage and handling

each 5 mL teaspoonful contains: calcium 160mg, magnesium 55 mg refrigerate after opening to preserve freshness and purity do not freeze keep tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 400 mg
Magnesium hydroxide 135 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms
  • overindulgence in food and drink

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
Antacids may interact with certain prescription drugs.
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 use
  • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor
  • do not take more than 18 teaspoonfuls in a 24 hour period or use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL teaspoonful contains: calcium 160mg, magnesium 55 mg
  • refrigerate after opening to preserve freshness and purity
  • do not freeze
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sorbic acid, 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
237865calcium carbonate 400 MG / magnesium hydroxide 135 MG in 5 mL Oral SuspensionPSN5
237865calcium carbonate 80 MG/ML / magnesium hydroxide 27 MG/ML Oral SuspensionSCD5
237865calcium carbonate 400 MG / milk of magnesia 135 MG per 5 ML Oral SuspensionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-624-12SUPREME ANTACID355 mL in 1 BOTTLESUSPENSION3555

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-62455319-624-12

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DIMETHICONE92RU3N3Y1OIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
BENZYL ALCOHOLLKG8494WBHIACT

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
SUPREME ANTACIDCALCIUM CARBONATE, MAGNESIUM HYDROXIDEFAMILY DOLLAR SERVICES INC5e996df3-25a4-b259-e053-2a91aa0a43112025-11-19WarningsExact identifier
ndc (package): 55319-624-12
ndc (product): 55319-624
ndc11 (package): 55319062412
spl id: 43f5b769-711e-58cf-e063-6394a90a5674
spl set id: 5e996df3-25a4-b259-e053-2a91aa0a4311

Reported adverse events (FAERS/openFDA)#

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