ADVANCED ANTACID REGULAR STRENGTH

Manufacturer
STRATEGIC SOURCING SERVICES LLC | GCP Laboratories
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:22:39

Label at a glance#

ProductADVANCED ANTACID REGULAR STRENGTH
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure8 sections

Indications and uses

relieves heartburn sour stomach acid indigestion the symptoms referred to as 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 under 12 years: ask a doctor

Storage and handling

each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg protect from freezing store at room temperature keep tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 200mg (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
  • the symptoms referred to as 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

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 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 under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL teaspoonful contains: magnesium 85 mg, sodium 1 mg
  • protect from freezing
  • store at room temperature
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunmark

compare to active ingredients of the Regular Strength Mylanta®*

NDC 49348-153-39

advanced

antacid

Regular Strength

antacid/antigas

Alumina, Magnesia
and Simethicone
Oral Suspension

Fast acting
soothing relief of
heartburn,
acid indigestion,
sour stomach,
pressure & bloating

ORIGINAL FLAVOR

Alcohol 0.15%

12 FL OZ (355 mL)

sun rssun rs

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-153-39ML - Milliliter49348-1535e5de8a8-0bb8-485d-8592-55f0d66a014112016-09-02

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-15349348-153-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
091c6971-5cf4-3eec-e063-6294a90a02763ac2be80-bfd3-06a8-e054-00144ff8d46c2023-11-01WarningsExact identifier
spl id: 091c6971-5cf4-3eec-e063-6294a90a0276
spl set id: 3ac2be80-bfd3-06a8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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