Actidose Suspension
FDA Label NDC 0574-0520

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Padagis Us Llc for the product Actidose (NDC 0574-0520). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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 seal. 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

    Do not use

    25 – 50 g (120 – 240 mL) do not use 25 g in child weighing less than 16 kg (35 pounds) do not use 50 g in child weighing less than 32 kg (70 pounds)

    50 g (240 mL)

    Multiple Dose

    Not recommended for children or adults

    • 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, sorbitol, and water.

Questions?

Please call 1-800-328-5113

Package/Label Principal Display Panel

NDC 0574-0520-04

ACTIDOSE® with SORBITOL

ACTIVATED CHARCOAL SUSPENSION

25 grams Activated Charcoal

48 grams Sorbitol

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. 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 (Image 01)

Label (Image 01)

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