Label: INSTA-CHAR SORBITOL- poison adsorbent suspension

  • NDC Code(s): 66689-203-04, 66689-203-08
  • Packager: VISTAPHARM INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 4, 2018

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    If possible call a Poison Control Center, emergency medical facility, or health professional for help before using this product. If help cannot be reached quickly, follow directions on this label. Read the warnings and directions as soon as you buy this product. Insert emergency phone number(s) in space provided below on the label.

    Close
  • Active Ingredient (per 120 mL)

    Activated Charcoal, USP 25g

    Close
  • Purpose

    Poison Adsorbent

    Close
  • Uses

    • For emergency use to adsorb swallowed poisons.
    Close
  • Warnings

    Do not use

    • until after the patient has vomited, unless directed by a health professional
    • in persons that are not fully conscious
    • 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

    When using this product

    severe cramping and diarrhea may be experienced.

    If Pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Close
  • 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 to insert drinking straw included with bottle.
    • Pull or cut off tip from included cherry flabor and squeeze flavor into straw.
    • Administer entire 240 mL if possible.
    • Repeat dose immediately with Insta-Char Aqueous base product if possible.
    • If previous attempts to contact a poison control center. emergency medical facility, of health professionsl were unsuccessful, continue trying.
    • Keep patient active and moving.
    • Save the container of poison.

    Age Dose

    Children 1 to 12 years old weighing at least 16kg (36lbs.)

    Adults and children 12 and over and weighing at least 32 kg (71 lbs.)

    15 -30g activated charcoal or 1-2g per kg of body weight. If a second dose is recommended, the additional dose should be Insta-Char in an Aqueous Base unless otherwise directed by a physician.

    50-100 g (1-2 adult bottles) or 1-2g per kg of body weight. If a second bottle is recommended, the additional bottle should be Insta-Char in an Aqueous Base unless otherwise directed by a physician.

    Close
  • Other information

    • Drinking straw and cherry flavor included

    Close
  • Inactive Ingredients

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

    Flavor Ingredients
    artificial flavor, citric acid, FD and C red #40, propylene glycol, sodium benzoate, water, xanthan gum

    Close
  • Questions?

    888-655-1505

    Close
  • Label

    The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

    Inst-Char Sorbitol Poison adsorbent 120 mL

    Distributed by:

    Vistapharm Inc.

    Largo, FL 33771

    InstaCharSorb

    Close
  • INGREDIENTS AND APPEARANCE
    INSTA-CHAR SORBITOL 
    poison adsorbent suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-203
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 50 g  in 240 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (CONTAINED IN 1ML PACKET) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-203-08 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2008
    2 NDC:66689-203-04 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part357 03/28/2008
    Labeler - VISTAPHARM INC (116743084)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    Name Address ID/FEI Business Operations
    DSC Laboratories Inc. 097807374 manufacture(66689-203)
    Close