ACTIDOSE AQUA- activated charcoal suspension

ACTIDOSE AQUA by

Drug Labeling and Warnings

ACTIDOSE AQUA by is a Otc medication manufactured, distributed, or labeled by Paddock Laboratories, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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: 0574-0521-74

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)

INGREDIENTS AND APPEARANCE

ACTIDOSE AQUA 
activated charcoal suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0574-0521
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)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0574-0521-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020
2	NDC: 0574-0521-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2020
3	NDC: 0574-0521-25	72 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2023
4	NDC: 0574-0521-74	120 mL in 1 TUBE; Type 0: Not a Combination Product	11/10/2020
5	NDC: 0574-0521-76	240 mL in 1 TUBE; Type 0: Not a Combination Product	12/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part357	11/10/2020

Labeler - Padagis US LLC (967694121)