Label: ACTIDOSE- activated charcoal suspension
- NDC Code(s): 0574-0520-04, 0574-0520-08, 0574-0520-74, 0574-0520-76
- Packager: Padagis US 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.
Updated December 11, 2021
If you are a consumer or patient please visit this version.
- Active ingredient
- 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
- 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)
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)
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
- Inactive Ingredients
Package/Label Principal Display Panel
ACTIDOSE® with SORBITOL
ACTIVATED CHARCOAL SUSPENSION
25 grams Activated Charcoal
48 grams Sorbitol
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)
INGREDIENTS AND APPEARANCE
activated charcoal suspension
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0574-0520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 208 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0574-0520-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2020 2 NDC:0574-0520-08 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/10/2021 3 NDC:0574-0520-74 120 mL in 1 TUBE; Type 0: Not a Combination Product 02/19/2021 4 NDC:0574-0520-76 240 mL in 1 TUBE; Type 0: Not a Combination Product 12/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part357 12/05/2020 Labeler - Padagis US LLC (967694121)