FDA.reportPublic FDA data

shoprite antacid

Manufacturer
Wakefern Food Corporation
Effective date
2018-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:43:21

Label at a glance#

Productshoprite antacid
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

for the relief of • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms • pressure and bloating commonly referred to as gas

Dosage and administration

• shake well before using • only use the dose cup provided • adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician • do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks • children under 12 years: consult a physician

Storage and handling

• each 10 mL contains: magnesium 175 mg • does not meet USP requirements for preservative effectiveness • store at 20-25ºC (68-77ºF) • protect from freezing

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • acid indigestion
  • heartburn
  • sour stomach
  • upset stomach associated with these symptoms
  • pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • only use the dose cup provided
  • adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
  • do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
  • children under 12 years: consult a physician

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: magnesium 175 mg
  • does not meet USP requirements for preservative effectiveness
  • store at 20-25ºC (68-77ºF)
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-SHOPRITE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to: Active Ingredients in Maalox® Advanced

REGULAR STRENGTH

ANTACID

ANTACID/ANTI-GAS

Advanced

Fast Relief of:

Heartburn – Acid Indigestion – Pressure - Bloating

Mint Flavor

12 FL OZ (355 mL)

antacid image
antacid image

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41190-85141190-851-40

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
ALUMINUM HYDROXIDE5QB0T2IUN0ACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
DIMETHICONE92RU3N3Y1OACTIB
BUTYLPARABEN3QPI1U3FV8IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

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
5b306a7f-d92f-4a33-b436-d5b88c7455e6d538e2cb-3cfe-4d59-afc6-352e4ba8d2a22020-12-02WarningsExact identifier
spl set id: d538e2cb-3cfe-4d59-afc6-352e4ba8d2a2

Reported adverse events (FAERS/openFDA)#

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