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INSTA-CHAR AQUEOUS

INSTA-CHAR AQUEOUS

Approved
Approval ID

b77f8597-5fd1-4ea9-8e3b-90fe43050425

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 16, 2025

Manufacturers
FDA

VistaPharm, LLC

DUNS: 048458728

Products 1

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

POISON TREATMENT ADSORBENT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66689-113
Application NumberM023
Product Classification
M
Marketing Category
C200263
G
Generic Name
POISON TREATMENT ADSORBENT
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2025
FDA Product Classification

INGREDIENTS (6)

ACTIVATED CHARCOALActive
Quantity: 25 g in 240 mL
Code: 2P3VWU3H10
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/16/2025

PRINCIPAL DISPLAY PANEL-CARTON

NDC 66689-113-08

INSTA-CHAR™
IN AN AQUEOUS BASE

Activated Charcoal Suspension
Poison Adsorbet

Distributed by:

VistaPharm, LLC
Parsippany, NJ 07054

![Carto of Instaschar in an Aqueous base](/dailymed/image.cfm?name=insta-char- aqueous-base-2.jpg&id=897035)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/8/2025

Use

  • for emergency use to adsorb swallowed poisons

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/8/2025

Active ingredient (in each 240 mL)

Activated charcoal, USP 25 g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/8/2025

Purpose

Poison adsorbent

WARNINGS SECTION

LOINC: 34071-1Updated: 1/8/2025

Warnings

*Do not give activated charcoal until after patient has vomited unless directed by a health professional *Do not use in persons who are not fully conscious *Do not use this product unless directed by a health professional if turpentine, corrosives such as alkalies (lye) and strong acids or petroleum distillates, such as kerosene, gasoline, paint thinner, cleaning fluid or furniture polish have been ingested

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/8/2025

Directions

*SHAKE VIGOROUSLY TO SUSPEND CHARCOAL BEFORE USE *****remove foil seal underneath cap and replace cap

  • cut off delivery tip of bottle 3/4 inch from end for drinking
  • administer entire bottle, 25 g of activated charcoal in 240 mL, or as directed by a health professional
  • repeat dose immediately, if possible
  • if previous attempts to contact a poison control center, emergency medical facility, or health professional were unsuccessful, continue trying
  • keep patient active and moving
  • save the container of poison

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/8/2025

Other information

  • store at 20-25ºC (68-77ºF)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/29/2024

Inactive Ingredients

citric acid, glycerin, propylene glycol, purified water, sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/8/2025

Questions?

1-888-655-1505

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INSTA-CHAR AQUEOUS - FDA Drug Approval Details