FDA.reportPublic FDA data

leader antacid

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2021-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:28:06

Label at a glance#

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

Indications and uses

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

Dosage and administration

• shake well before use • measure with dosing cup provided • adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor • do not take more than 120 mL in any 24 hour period • do not use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor • mL = milliliter

Storage and handling

• each 10 mL contains: magnesium 175 mg • does not meet USP requirements for preservative effectiveness • store at 20-25 ° C (68-77 ° F), do not freeze

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

Purposes

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach due to 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 exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • measure with dosing cup provided
  • adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor
  • do not take more than 120 mL in any 24 hour period
  • do not use the maximum dosage for more than 2 weeks
  • children under 12 years: ask a doctor
  • mL = milliliter

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: magnesium 175 mg
  • does not meet USP requirements for preservative effectiveness
  • store at 20-25°C (68-77°F), do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Regular Strength

Antacid Liquid

Aluminum Hydroxide | Magnesium Hydroxide

Simethicone | Antacid | Antigas

Original Flavor

ALCOHOL 0.2%

Fast Relief of:

Heartburn

Acid Indigestion

Pressure & Bloating

100% Money Back Guarantee

12 FL OZ (355 mL)

antacid liquid image
antacid liquid image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0476-1ML - Milliliter70000-0476150e3fe3-7ef4-4180-9d0e-a9b6a04ea79e12019-09-05

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
70000-047670000-0476-1

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
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLPARABEN3QPI1U3FV8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
94352d0d-9dcb-48a6-a780-01341150800966a7f372-c100-4b91-899b-39b5e236aab42021-11-11WarningsExact identifier
spl id: 94352d0d-9dcb-48a6-a780-013411508009
spl set id: 66a7f372-c100-4b91-899b-39b5e236aab4

Reported adverse events (FAERS/openFDA)#

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