FDA Label for Actidose
View Indications, Usage & Precautions
Actidose Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Us Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.• 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.
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 | ||
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)
* Please review the disclaimer below.