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Questions & Answers
Side Effects & Adverse Reactions
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
ORBIVAN™ Butalbital, Acetaminophen and Caffeine capsules 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.
There is currently no drug history available for this drug.
ORBIVAN™ Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital USP……………………50 mg
Acetaminophen USP…………….300 mg
Caffeine USP……………………..40 mg
Inactive Ingredients: sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, d&c yellow # 10, fd&c red#40, titanium dioxide, fd&c blue#1, fd&c yellow #6, gelatin.
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 212.25. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula: