ACTIDOSE AQUA- activated charcoal suspension 
Padagis US LLC

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.

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ACTIDOSE®-Aqua Drug Facts

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
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 - Padagis US LLC (967694121)

Revised: 12/2021
Document Id: 89329543-e9dd-456b-95f6-13e33bc28734
Set id: c85dc235-3f42-4361-9bd2-1aaff798ad75
Version: 4
Effective Time: 20211207
 
Padagis US LLC