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

DRUG ABUSE AND DEPENDENCE

Abuse

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs (see WARNINGS).

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, Scopolamine Hydrobromide Elixir 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, Scopolamine Hydrobromide 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

HOW SUPPLIED

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir — Grape is a purple colored, grape flavored liquid.

• 4 fl oz (118 mL) bottles- NDC 50742-666-04.
• 1 Pint (473 mL) bottles- NDC 50742-666-16.

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir — Mint is a green colored, mint flavored liquid.

• 4 fl oz (118 mL) bottles- NDC 50742-665-04.
• 1 Pint (473 mL) bottles- NDC 50742-665-16.

Avoid Freezing

Store Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide Elixir 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-122298-01
MPL-100

logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 4 OZ GRAPE

NDC 50742-666-04
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Elixir Grape Flavored
Each 5 mL (1 teaspoonful) contains:
Phenobarbital, USP…………………… 16.2 mg
Hyoscyamine Sulfate, USP……….. 0.1037 mg
Atropine Sulfate, USP………………. 0.0194 mg Scopolamine Hydrobromide, USP….0.0065 mg

Alcohol not more than 23.8%

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

Rx Only

4 FL OZ

Ingenus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 1 PINT GRAPE

NDC 50742-666-16

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Elixir Grape Flavored
Each 5 mL (1 teaspoonful) contains:
Phenobarbital, USP…………………… 16.2 mg
Hyoscyamine Sulfate, USP……….. 0.1037 mg
Atropine Sulfate, USP………………. 0.0194 mg
Scopolamine Hydrobromide, USP….0.0065 mg
Alcohol not more than 23.8%DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

Bulk Container-Not For Household Use

Rx Only

1 Pint

Ingenus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 4 OZ MINT

NDC 50742-665-04
Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Elixir Mint Flavored
Each 5 mL (1 teaspoonful) contains:
Phenobarbital, USP…………………… 16.2 mg
Hyoscyamine Sulfate, USP……….. 0.1037 mg
Atropine Sulfate, USP………………. 0.0194 mg
Scopolamine Hydrobromide, USP….0.0065 mg

Alcohol not more than 23.8%
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

Rx Only

4 FL OZ Ingenus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 1 PINT MINT

NDC 50742-665-16

Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide
Elixir Mint Flavored
Each 5 mL (1 teaspoonful) contains:
Phenobarbital, USP…………………… 16.2 mg
Hyoscyamine Sulfate, USP……….. 0.1037 mg
Atropine Sulfate, USP………………. 0.0194 mg
Scopolamine Hydrobromide, USP…..0.0065 mg

Alcohol not more than 23.8%

contains color additives including FD&C Yellow No. 5 (tartrazine)
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING

Bulk Container — Not For Household Use

Rx Only

1 Pint Ingenus

PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-666 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg in 5 mL HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg in 5 mL ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg in 5 mL SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN SORBITOL ALCOHOL SUCROSE SACCHARIN SODIUM FD&C RED NO. 3 FD&C BLUE NO. 1

Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE (Artificial and Natural Grape) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50742-666-04 118 mL in 1 BOTTLE None 2 NDC:50742-666-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 08/01/2021

PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide elixir

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-665 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg in 5 mL HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.1037 mg in 5 mL ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.0194 mg in 5 mL SCOPOLAMINE HYDROBROMIDE (SCOPOLAMINE) SCOPOLAMINE HYDROBROMIDE 0.0065 mg in 5 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN SORBITOL ALCOHOL SUCROSE SACCHARIN SODIUM FD&C YELLOW NO. 5 FD&C BLUE NO. 1

Product Characteristics Color GREEN Score Shape Size Flavor MINT (Natural Mint) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50742-665-04 118 mL in 1 BOTTLE None 2 NDC:50742-665-16 473 mL in 1 BOTTLE 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