Dosing & Uses
Dosage Forms & Strengths
tablet/capsule: Schedule III
1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day
Dosage Forms & Strengths
capsule: Schedule III
<16 years: Safety & efficacy not established
>16 years: As adults; 1-2 tab/cap PO q4hr; not to exceed 6 tab/cap per day
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
- Dizziness, drowsiness, feeling of intoxication, lightheadedness, sedation
- Abdominal pain, nausea, vomiting
- Shortness of breath
- Dyspepsia, heartburn, nausea, vomiting, stomach pain
- Tinnitus (high or chronic dose)
- Tachycardia, palpitations (dose dependent)
- Insomnia, irritability, nervousness, restlessness, tinnitus, tremor
- Diarrhea, nausea, vomiting
Children younger than 16 years old because of potential for Reye syndrome
Bronchospastic reaction to aspirin
Peptic ulcer disease
Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease
Gastrointestinal bleeding; particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders
Avoid driving car or operating machinery
Reye syndrome may occur in children because of aspirin component; do not use for chickenpox or flu symptoms
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
Pregnancy & Lactation
Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus because of aspirin component
Lactation: excreted in breast milk; do not breast feed
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Butalbital: Barbiturate; elicits generalized CNS depressant effects
Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2
Caffeine: Vasoconstrictive properties of cerebral blood vessels may be helpful when treating headaches
Protein binding: 45%
Absorption: Well absorbed
Half-life elimination: 35 hr
Excretion: Urine (59-88%)
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.