Humco Charcoal Activated
FDA Label NDC 0395-0527

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group. Inc. for the product Humco Charcoal Activated (NDC 0395-0527). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, warning:, use, warnings, keep out of reach of children., directions for 1 oz bottle, directions for 8 oz bottle, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Charcoal Activated

Purpose

First Aid Poison Adsorbent

Warning:

Do not use if Tamper Evident Seal imprinted "Sealed for Your Protection" is broken or missing. This product is sealed with either a shrink band around the cap or foil seal under cap.

Use

For emergency use to adsorb swallowed poisons.

Warnings

  • Do not give Activated Charcoal until after 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 didtillates, such as kerosene, gasoline, paint thinner, cleaning fluid or furniture polish have been ingested.
  • Do not give if poison victim is unconscious or having convulsions. Keep patient active and moving.

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions For 1 Oz Bottle

When Activated Charcoal is indicated for use, give 3 to 4 heaping tablespoonfulls (20 to 30 g) mixed in a minimum of 8 ounces of liquid or as directed by a health professional. If an emergency, fill this bottle with water.

Mix well and have poison victim drink all of this mixture. Repeat dose immediately, if possible. If previous attempts to contact a poison control center, emergency medical center or health professional were unsuccessful, continue trying. If possible save the container of poison.

Directions For 8 Oz Bottle

When Activated Charcoal is indicated, the usual dose is as follows:

  • 0-10 years of age: 1 to 3 heaping tablespoonfulls (10 -25 g) mixed in a minimum of 8 ounces of liquid.
  • 10 - 12 yrs of age: 3 - 6 tablespoonfulls (25 - 50 g) mixed in a minimum of 8 ounces of liquid.
  • Greater than 12 years of age: 3 to 12 tablespoonfulls (25 - 100g) mixed with a minimum of 8 ounces of liquid or as directed by a health professional. mix well and have poison victim drink all of this mixture. Repeat dose immediately, if possible. If the previous attempts to contact poison control center, emergency medical center or health professional were unsuccessful, continue trying. If possible save the container of poison.

Other Information

  • Activated Charcoal has a very gritty texture and will coat the mouth, lips and tonge.
  • Keep tightly closed in a cool dry place.

Inactive Ingredients

None

Principal Display Panel

1 oz label

8 oz label

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