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ORBIVAN™ Butalbital, Acetaminophen and Caffeine Capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
DOSAGE AND ADMINISTRATION
1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
ORBIVAN™ Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg/300 mg/40 mg
Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules
(NDC 59702-661-01) and in unit dose sample pouches for patient trial available only through physician offices
Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature];
Dispense in a tight, light-resistant container.
Medical Economics Company, Inc.
Last reviewed on RxList: 8/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Orbivan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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