BUTALBITAL, ASPIRIN, AND CAFFEINE: Package Insert and Label Information (Page 2 of 2)

Treatment

Treatment consists of primarily of management of barbiturate intoxication and the correction of the acid-base imbalance due to salicylism. Vomiting should be induced mechanically or with emetics in the conscious patient. Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration. Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as 1% sodium bicarbonate in 5% dextrose in water. Meticulous attention should be given to maintaining adequate pulmonary ventilation. The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow. However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed^®)1 may be given I.V. with the usual precautions and serial blood pressure monitoring. In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving. Hypoprothrombinemia should be treated with Vitamin K, intravenously.

Up-to-date information about the treatment of overdose can often be obtained from a Certified Regional Poison Control Center. Telephone numbers of Certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference^® 2.

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1

Levophed is a registered Trademark of Sanofi Winthrop Pharmaceuticals.

2

Trademark of Medical Economics Company, Inc.

Toxic and Lethal Doses

Butalbital: toxic dose 1 g (20 capsules of butalbital, aspirin, and caffeine)

Aspirin: toxic blood level greater than 30 mg/100mL; lethal dose 10 to 30 g

Caffeine: toxic dose 1 g (25 capsules of butalbital, aspirin, and caffeine)

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Butalbital, aspirin, and caffeine capsules, USP are supplied as follows:

Butalbital 50 mg, aspirin 325 mg, caffeine 40 mg capsules are green opaque/white opaque, imprinted MUTUAL/779, on both the cap and the body.

Bottles of 30	NDC 53489-622-07
Bottles of 60	NDC 53489-622-06
Bottles of 100	NDC 53489-622-01
Bottles of 250	NDC 53489-622-03
Bottles of 500	NDC 53489-622-05
Bottles of 1000	NDC 53489-622-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature].

Protect from moisture.

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Revised: September 2006S

BUTALBITAL, ASPIRIN, AND CAFFEINE butalbital, aspirin, and caffeine capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-622 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength butalbital (butalbital) butalbital 50 mg aspirin (aspirin) aspirin 325 mg caffeine (caffeine) caffeine 40 mg

Inactive Ingredients Ingredient Name Strength Alginic acid corn starch pregelatinized starch sodium lauryl sulfate talc FD&C Blue #2 FDA/E172 yellow iron oxide gelatin titanium dioxide D&C Yellow #10 FD&C Blue #1 FD&C Red #40 iron oxide black propylene glycol

Product Characteristics Color GREEN (green opaque) , WHITE (white opaque) Score no score Shape CAPSULE (capsule) Size 18mm Flavor Imprint Code MUTUAL;779 Contains Coating false Symbol false

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53489-622-07 30 CAPSULE (30 CAPSULE) in 1 BOTTLE, PLASTIC None 2 NDC:53489-622-06 60 CAPSULE (60 CAPSULE) in 1 BOTTLE, PLASTIC None 3 NDC:53489-622-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None 4 NDC:53489-622-03 250 CAPSULE (250 CAPSULE) in 1 BOTTLE, PLASTIC None 5 NDC:53489-622-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC None 6 NDC:53489-622-10 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE, PLASTIC None

Labeler — MUTUAL PHARMACEUTICAL COMPANY, INC.

Revised: 06/2007 MUTUAL PHARMACEUTICAL COMPANY, INC.