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NDC 00574-0520-04 ACTIDOSE 208 mg/mL Details
ACTIDOSE 208 mg/mL
ACTIDOSE is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is ACTIVATED CHARCOAL.
Product Information
| NDC | 00574-0520 |
|---|---|
| Product ID | 0574-0520_25f1d299-8fda-4342-93e0-8965c9dd506c |
| Associated GPIs | 93000010200900 |
| GCN Sequence Number | 057761 |
| GCN Sequence Number Description | charcoal/sorbitol solution ORAL SUSP 25 G/120ML ORAL |
| HIC3 | C8E |
| HIC3 Description | ANTIDOTES,MISCELLANEOUS |
| GCN | 22989 |
| HICL Sequence Number | 001116 |
| HICL Sequence Number Description | ACTIVATED CHARCOAL/SORBITOL SOLUTION |
| Brand/Generic | Brand |
| Proprietary Name | ACTIDOSE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | activated charcoal |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 208 |
| Active Ingredient Units | mg/mL |
| Substance Name | ACTIVATED CHARCOAL |
| Labeler Name | Padagis US LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part357 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00574-0520-04 (00574052004)
| NDC Package Code | 0574-0520-04 |
|---|---|
| Billing NDC | 00574052004 |
| Package | 120 mL in 1 BOTTLE (0574-0520-04) |
| Marketing Start Date | 2020-12-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 76e4fe6a-afd4-4f68-b12d-0b094f750615 Details
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.
Directions
- •
- Shake well.
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- Unscrew cap and remove foil seal. 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.
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Under 1 year |
1 – 12 years |
Adults (over 12 years) |
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Single Dose |
Do not use |
25 – 50 g (120 – 240 mL) do not use 25 g in child weighing less than 16 kg (35 pounds) do not use 50 g in child weighing less than 32 kg (70 pounds) |
50 g (240 mL) |
|
Multiple Dose |
Not recommended for children or adults |
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- •
- 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
Package/Label Principal Display Panel
NDC 0574-0520-04
ACTIDOSE® with SORBITOL
ACTIVATED CHARCOAL SUSPENSION
25 grams Activated Charcoal
48 grams Sorbitol
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. 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
activated charcoal suspension |
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| Labeler - Padagis US LLC (967694121) |