Label: EZ CHAR- activated charcoal pellet

  • Category: HUMAN OTC DRUG LABEL

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 6, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each bottle)

    Activated charcoal 25 grams

  • Purpose

    Poison adsorbent

  • Use

    for emergency use to adsorb swallowed poisons

  • Warnings

    do not give activated charcoal until after the patient has vomited unless directed by health professional
    do not use in persons who are not fully conscious
    do not use this product, unless directed by 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
    TAMPER EVIDENT: DO NOT USE IF PROTECTIVE SEAL IS BROKEN OR MISSING
  • Keep out of reach of children.

    In case of accidental ingestion, contact a Poison Control Center immediately.

  • Directions

    Remove Seal. Reconstitute into an oral suspension by adding 4 oz. of water to bottle, replacing cap and shaking well, or by pouring contents into a separate container, adding 4 oz. water, and stirring thoroughly.

    USE IMMEDIATELY, DO NOT STORE RECONSTITUTED PRODUCT.

    6 to 12 lb

    1 to 2 TBS of reconstituted liquid

    12 to 24 lb

    2 to 4 TBS of reconstituted liquid

    24 to 48 lb

    4 to 8 TBS of reconstituted liquid

    48 lb +

    entire amount of reconstituted liquid

    Repeat dose immediately, if necessary.

  • Other information

    each bottle contains: magnesium 35 mg, potassium 18 mg, sodium 57 mg
    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
    store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
  • Inactive ingredient

    bentonite

  • Questions?

    1-800-328-5113 Serious side effects associated with use of this product may be reported to this number.

  • Package/Label Principal Display Panel

    EZ Char®

    ACTIVATED CHARCOAL PELLETS

    POISON ADSORBENT

    Read label warnings and directions upon buying this product. For help using this product call a Poison Control Center, emergency medical facility, or health professional. If help cannot be reached quickly, follow the directions on the label. In case of poisoning call your Poison Control Center at 1-800-222-1222.

    NET WEIGHT 0.88 oz (25 grams)

    label-rev05-19
  • INGREDIENTS AND APPEARANCE
    EZ CHAR 
    activated charcoal pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-0122
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL25 g  in 25 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    Product Characteristics
    ColorBLACKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-0122-2525 g in 1 BOTTLE; Type 0: Not a Combination Product01/14/200211/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35701/14/200211/30/2025
    Labeler - Padagis US LLC (967694121)