Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide (Page 2 of 2)

Dependence

In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

OVERDOSAGE

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride should be used.

DOSAGE AND ADMINISTRATION

The dosage of Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets — Adults: One or two Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets three or four times a day according to condition and severity of symptoms.

HOW SUPPLIED

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets are supplied as: white, D-shaped, flat faced beveled edge tablets embossed “D” on one side and debossed “DONNATAL” on the other side.

  • Bottles of 100 tablets- NDC 50742-667-01.

Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

DEA EXEMPT PRODUCT

Manufactured for:

Ingenus Pharmaceuticals, LLC

Orlando, FL 32839-6408

Revised: 05/2021

LF-122302-01

MPL-095

logologo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50742-667-01

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate and Scopolamine Hydrobromide Tablets

Each tablet contains:

Phenobarbital, USP ………………………….……… 16.2 mg

Hyoscyamine Sulfate, USP ………………….…… 0.1037 mg

Atropine Sulfate, USP ……………………………. 0.0194 mg

Scopolamine Hydrobromide, USP ……………….. 0.0065 mg

Rx Only

100 Tablets

Ingenus

container
(click image for full-size original)
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE AND SCOPOLAMINE HYDROBROMIDE
phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-667
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg
SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SUCROSE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
STEARIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape SEMI-CIRCLE Size 8mm
Flavor Imprint Code D;DONNATAL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-667-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2021
Labeler — Ingenus Pharmaceuticals, LLC (833250017)

Revised: 08/2021 Ingenus Pharmaceuticals, LLC

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