FDA.reportPublic FDA data

SUPREME ANTACID

Manufacturer
Chain Drug Consortium, LLC | GCP Laboratories
Effective date
2017-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:06:09

Label at a glance#

ProductSUPREME ANTACID
Active ingredientCALCIUM CARBONATE, MAGNESIUM HYDROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

shake well before each use adults and children 12 years and older: take 2 to 4 teaspoonfuls, as needed, between meals, at bedtime, or as directed by a doctor. Do not take more than 18 teaspoonfuls in 24 hours unless directed by a doctor 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 protect from freezing keep tightly closed TAMPER-EVIDENT: Do not use if breakaway band on bottle cap is missing or broken.

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

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 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 each use
  • adults and children 12 years and older: take 2 to 4

teaspoonfuls, as needed, between meals, at bedtime, or as
directed by a doctor. Do not take more than 18 teaspoonfuls
in 24 hours unless directed by a doctor

  • 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
  • protect from freezing
  • keep tightly closed
  • TAMPER-EVIDENT: Do not use if
    breakaway band on bottle cap is missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, flavor, hydroxyethylcellulose, purified water, saccharin sodium, simethicone emulsion, sorbic acid, sorbitol solution, xanthan gum

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPSUP

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
68016-62468016-624-12

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
BENZYL ALCOHOLLKG8494WBHIACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45IACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
DIMETHICONE92RU3N3Y1OIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM CARBONATEH0G9379FGKACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB

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
d3ace6da-8698-db5d-e053-2995a90a8f0960debb08-ce4e-0da0-e053-2a91aa0ae1782021-12-21WarningsExact identifier
spl set id: 60debb08-ce4e-0da0-e053-2a91aa0ae178

Reported adverse events (FAERS/openFDA)#

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