Label: ACTIDOSE AQUA- activated charcoal suspension
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NDC Code(s):
0574-0521-04,
0574-0521-08,
0574-0521-25,
0574-0521-74, view more0574-0521-76
- 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.
Drug Label Information
Updated December 7, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
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- do not give activated charcoal until after the patient has vomited unless directed by a health professional.
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- do not use in persons who are not fully conscious.
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- 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
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Directions
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- Shake well.
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- Unscrew cap and remove foil. Replace cap to administer.
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- 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 hours25 – 50 g
(120 – 240 mL)
every 4 – 6 hours50 – 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
- Inactive Ingredients
- Questions?
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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)
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INGREDIENTS AND APPEARANCE
ACTIDOSE AQUA
activated charcoal suspensionProduct 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)
