Label: ACTIDOSE AQUA- activated charcoal suspension

  • NDC Code(s): 0574-0521-04, 0574-0521-08, 0574-0521-25, 0574-0521-74, view more
    0574-0521-76
  • Packager: Paddock Laboratories, LLC.
  • 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 14, 2020

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

  • Active ingredient

    Activated Charcoal

  • 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 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.
  • Keep Out of Reach of Children

  • Directions

    Shake well.
    Unscrew cap and remove foil. Replace cap to administer.
    If delivering entire container to patient, rinse container with water and give residue to patient to ensure entire dose has been delivered.

    Under 1 year

    1 – 12 years

    Adults (over 12 years)

    Single Dose

    1 g/kg
    (5 mL/kg)

    25 – 50 g
    (120 – 240 mL)

    50 – 100 g
    (240 – 480 mL)

    Multiple Dose

    1 g/kg
    (5 mL/kg)
    every 4 – 6 hours

    25 – 50 g
    (120 – 240 mL)
    every 4 – 6 hours

    50 – 100 g
    (240 – 480 mL)
    every 4 – 6 hours

    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 information

    Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Do not refrigerate.
  • Inactive Ingredients

    Citric acid, glycerin, propylene glycol, sucrose, and water.

  • Questions?

    Please call 1-800-328-5113

  • Package/Label Principal Display Panel

    NDC 0574-0521-04

    ACTIDOSE®-Aqua

    ACTIVATED CHARCOAL SUSPENSION

    25 grams Activated Charcoal

    POISON ADSORBENT

    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 label warnings and directions upon buying this product. Write emergency phone numbers in space provided.

    Local Poison control Center: 1-800-222-1222

    Emergency Phone Number:

    WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.

    NET CONTENTS: 120 mL (4 fl oz)

    label
  • INGREDIENTS AND APPEARANCE
    ACTIDOSE AQUA 
    activated charcoal suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-0521
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL208 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0574-0521-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
    2NDC:0574-0521-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2020
    3NDC:0574-0521-2572 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2099
    4NDC:0574-0521-74120 mL in 1 TUBE; Type 0: Not a Combination Product11/10/2020
    5NDC:0574-0521-76240 mL in 1 TUBE; Type 0: Not a Combination Product12/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35711/10/2020
    Labeler - Paddock Laboratories, LLC. (967694121)