NDC 0574-0521 Actidose Aqua

Activated Charcoal

NDC Product Information

Actidose Aqua with NDC 0574-0521 is a a human over the counter drug product labeled by Paddock Laboratories, Llc.. The generic name of Actidose Aqua is activated charcoal. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Paddock Laboratories, Llc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Actidose Aqua Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACTIVATED CHARCOAL 208 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Paddock Laboratories, Llc.
Labeler Code: 0574
FDA Application Number: part357 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-10-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Actidose Aqua Product Label Images

Actidose Aqua Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

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 year1 – 12 yearsAdults (over 12 years)Single Dose1 g/kg(5 mL/kg)25 – 50 g(120 – 240 mL)50 – 100 g(240 – 480 mL)Multiple Dose1 g/kg(5 mL/kg)every 4 – 6 hours25 – 50 g(120 – 240 mL)every 4 – 6 hours50 – 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

* Please review the disclaimer below.