FDA.reportPublic FDA data

ANTACID REGULAR STRENGTH

Manufacturer
FREDS, INC | GCP Laboratories
Effective date
2020-11-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:06:39

Label at a glance#

ProductANTACID REGULAR STRENGTH
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

relieves heartburn sour stomach acid indigestion upset stomach due to these symptoms symptoms of gas

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 24 teaspoonfuls in 24 hours 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: magnesium 85 mg, sodium 1 mg do not freeze store at room temperature tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

Purposes

OTC - PURPOSE SECTION

Antacid
Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms
  • symptoms of gas

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

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 24 teaspoonfuls in 24 hours 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: magnesium 85 mg, sodium 1 mg
  • do not freeze
  • store at room temperature tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREDSFREDS

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
55315-62955315-629-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

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
b468105a-c957-ddfc-e053-2995a90acd1160b681d3-4f37-88d4-e053-2991aa0a264e2020-11-18WarningsExact identifier
spl id: b468105a-c957-ddfc-e053-2995a90acd11
spl set id: 60b681d3-4f37-88d4-e053-2991aa0a264e

Reported adverse events (FAERS/openFDA)#

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