leader antacid

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2021-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:40:27

Label at a glance#

Productleader 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

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Regular Strength

Antacid Liquid

Aluminum Hydroxide | Magnesium Hydroxide

Simethicone | Antacid | Antigas

Mint Flavor

Fast Relief of:

Heartburn

Acid Indigestion

Pressure & Bloating

100% Money Back Guarantee

12 FL OZ (355 mL)

851-e9-antacid-liquid.jpg
851-e9-antacid-liquid.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0486-1ML - Milliliter70000-04862f248b82-0a43-409c-8214-6159e043cbeb12019-11-12

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
70000-048670000-0486-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
8dcb6b1a-fb05-4a57-ad8d-531fad875f91965eee72-2455-4442-8591-7da4bcfe26962021-07-14WarningsExact identifier
spl id: 8dcb6b1a-fb05-4a57-ad8d-531fad875f91
spl set id: 965eee72-2455-4442-8591-7da4bcfe2696

Reported adverse events (FAERS/openFDA)#

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