REGULAR STRENGTH ANTACID

Manufacturer
STRATEGIC SOURCING SERVICES LLC | GCP Laboratories
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:22:44

Label at a glance#

ProductREGULAR STRENGTH ANTACID
Active ingredientALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONE
Label structure9 sections

Indications and uses

relieves heartburn sour stomach acid indigestion the symptoms referred to as gas

Dosage and administration

• shake well before each use • adults and children 12 years and older: take 10 mL to 20 mL (1-2 doses) four times a day or as directed by a doctor • do not exceed 80 mL (8 doses) in a 24 hour period or use the maximum dosage for more than 2 weeks • children under 12 years: ask a doctor

Storage and handling

• each 10 mL dose contains: magnesium 165 mg, sodium 6 mg • store at room temperature • protect from freezing • keep tightly closed

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL dose)

OTC - ACTIVE INGREDIENT SECTION

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)

Magnesium hydroxide 400 mg

Simethicone 40mg

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 each use

• adults and children 12 years and older: take 10 mL to 20 mL
(1-2 doses) four times a day or as directed by a doctor
• do not exceed 80 mL (8 doses) in a 24 hour period or use the
maximum dosage for more than 2 weeks
• children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each 10 mL dose contains: magnesium 165 mg, sodium 6 mg
• store at room temperature

• protect from freezing
• keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0115-1ML - Milliliter70677-0115559e784e-2387-401e-a2b0-6eb617a963bb12021-07-15

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
70677-011570677-0115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
091c35a0-b086-20e9-e063-6294a90a99f5b2a96960-6916-61f2-e053-2a95a90aabed2023-11-01WarningsExact identifier
spl id: 091c35a0-b086-20e9-e063-6294a90a99f5
spl set id: b2a96960-6916-61f2-e053-2a95a90aabed

Reported adverse events (FAERS/openFDA)#

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