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FDA Approval

GERI-LANTA ANTACID ANTIGAS

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Effective Date
May 12, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Aluminum hydroxide(200 mg in 5 mL)
Magnesium hydroxide(200 mg in 5 mL)
Dimethicone(20 mg in 5 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

ATLANTIC BIOLOGICALS CORP.

047437707

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

GERI-LANTA ANTACID ANTIGAS

Product Details

NDC Product Code
17856-0630
Application Number
M001
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
May 12, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28DClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
Aluminum hydroxideActive
Code: 5QB0T2IUN0Class: ACTIBQuantity: 200 mg in 5 mL
Magnesium hydroxideActive
Code: NBZ3QY004SClass: ACTIBQuantity: 200 mg in 5 mL
DimethiconeActive
Code: 92RU3N3Y1OClass: ACTIBQuantity: 20 mg in 5 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package Label

image description

INDICATIONS & USAGE SECTION

Uses

relieves

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 12 years: ask a doctor

WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are presently 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.

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Other information

***each 5 mL teaspoonful contains:**magnesium 85 mg, sodium 3 mg

  • store at room temperature
  • protect from freezing
  • keep tightly closed

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)
Magnesium hydroxide 200 mg
Simethicone 20mg

OTC - PURPOSE SECTION

Purposes

Antacid
Antigas

OTC - QUESTIONS SECTION

Questions or comments?

1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

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