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GERI-LANTA ANTACID ANTIGAS

Geri-lanta original 629

Approved
Approval ID

043207dd-5e1c-4c78-b75a-7d341d71b117

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

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

aluminum hydroxide, magnesium hydroxide, dimethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-0630
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
aluminum hydroxide, magnesium hydroxide, dimethicone
Product Specifications
Route of AdministrationORAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
ALUMINUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: 5QB0T2IUN0
Classification: ACTIB
MAGNESIUM HYDROXIDEActive
Quantity: 200 mg in 5 mL
Code: NBZ3QY004S
Classification: ACTIB
DIMETHICONEActive
Quantity: 20 mg in 5 mL
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2024

package Label

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/18/2020

Uses

relieves

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/30/2024

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

LOINC: 55105-1Updated: 12/18/2020

Purposes

Antacid
Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 5/6/2024

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

LOINC: 44425-7Updated: 12/18/2020

Other information

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

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/18/2020

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/18/2020

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/18/2020

Questions or comments?

1-800-540-3765

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

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GERI-LANTA ANTACID ANTIGAS - FDA Drug Approval Details