Donnatal
DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only Revised: 02/20
4dba30db-7979-455f-a225-24f0a04d744e
HUMAN PRESCRIPTION DRUG LABEL
Jan 10, 2023
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
DESCRIPTION SECTION
Donnatal**®**Elixir - Mint
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
Phenobarbital, USP.............................. 16.2 mg
Hyoscyamine Sulfate, USP............... 0.1037 mg
Atropine Sulfate, USP...................... 0.0194 mg
Scopolamine Hydrobromide, USP.... 0.0065 mg
Inactive Ingredients
Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose.
Starting Dosage|
Body weight |
Every 4 hours |
Every 6 hours |
|
10 lb. (4.5 kg) |
0.5 mL |
0.75 mL |
|
20 lb. (9.1 kg) |
1 mL |
1.5 mL |
|
30 lb. (13.6 kg) |
1.5 mL |
2 mL |
|
50 lb. (22.7 kg) |
2.5 mL |
3.75 mL |
|
75 lb. (34 kg) |
3.75 mL |
5 mL |
|
100 lb. (45.4 kg) |
5 mL |
7.5 mL |