Actidose

Actidose® with Sorbitol and Actidose®-Aqua should be used in a supervised medical facility or under the direction of a physician or poison control center.

Actidose® with Sorbitol and Actidose®-Aqua are adjuncts in the management of poisoning emergencies. Prior to the use of activated charcoal, proper basic life support measures must be implemented as well as the appropriate gastric emptying technique if indicated.

When Actidose® with Sorbitol or Actidose®-Aqua are used to treat a poisoning emergency, the patient and health care providers should be aware that activated charcoal will produce black stools. These stools may be diarrhetic and may persist for several hours.

Actidose® with Sorbitol may produce a profound cathartic effect and proper attention should be given to the patient’s fluid and electrolyte needs. Actidose® with Sorbitol should be used cautiously in patients receiving multiple dose activated charcoal. If Actidose® with Sorbitol is used at each dosage interval, profound catharsis may develop which could result in dehydration, hypotension and significant electrolyte and fluid abnormalities.

A study conducted in healthy adult human volunteers who ingested therapeutic amounts of activated charcoal and sorbitol resulted in severe prolonged diarrhea, but no significant changes were noted in serum electrolytes or osmolality, BUN, or the metabolic profile as compared to the control.8

Gastrointestinal obstruction from activated charcoal may occur as a consequence of toxin-induced antiperistaltic effects. Actidose® with Sorbitol and Actidose®-Aqua should be used cautiously in patients who have been exposed to toxins which interfere with gastrointestinal tract peristalsis (i.e., anticholinergics, opioids, etc.). Bowel sounds should be frequently monitored to assess peristaltic action, especially in patients undergoing multiple dose activated charcoal therapy.

NDC 0574-0120-08

Actidose® with SORBITOL

ACTIVATED CHARCOAL SUSPENSION

50 grams Activated Charcoal

90 grams Sorbitol

POISON ADSORBENT

Emergency Treatment for Accidental Poisoning

See attached package insert for dosage instructions and additional information.

STORAGE: Store at 20° to 25°C (68° to 77°) [see USP Controlled Room Temperature]

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 under this label. Read label warnings and directions upon buying this product. Write emergency phone numbers in space provided.

Emergency Phone Number:

NET CONTENTS: 240 mL (8 fl oz)

DIRECTIONS:

Shake Well. Unscrew color-coded cap and remove foil seal. Replace cap to administer.

TAMPER EVIDENT:

DO NOT USE IF IMPRINTED PROTECTIVE SEAL UNDER THE CAP IS BROKEN OR MISSING.

NDC 0574-0121-08

Actidose®-AQUA

ACTIVATED CHARCOAL SUSPENSION

50 grams Activated Charcoal

POISON ADSORBENT

Emergency Treatment for Accidental Poisoning

See attached package insert for dosage instructions and additional information.

STORAGE: Store at 20° to 25°C (68° to 77°) [see USP Controlled Room Temperature]

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 under this label. Read label warnings and directions upon buying this product. Write emergency phone numbers in space provided.

Emergency Phone Number:

NET CONTENTS: 240 mL (8 fl oz)

DIRECTIONS:

Shake Well. Unscrew color-coded cap and remove foil seal. Replace cap to administer.

TAMPER EVIDENT:

DO NOT USE IF IMPRINTED PROTECTIVE SEAL UNDER THE CAP IS BROKEN OR MISSING.

Applies to charcoal: oral capsule

Other dosage forms:

• oral liquid

Capsules and tablets: 500 to 1040 mg up to 4 times daily as needed. Not effective in the treatment of poisoning.

No adjustment recommended

Charcoal has not been formally assigned to a pregnancy category by the FDA. No animal or human reproductive or fetotoxicity studies have been done. There appears to be no apparent toxicity associated with therapeutic dosages of activated charcoal administered once or for short periods of time.