Drugplain

Butalbital, Acetaminophen, Caffeine 325 mg/1

Butalbital, Acetaminophen, and Caffeine · TABLET · Asclemed USA, Inc.

No Recall History
Plain English

This is a prescription tablet containing a barbiturate combined with acetaminophen and caffeine, used to treat tension headaches and similar pain conditions. The combination works by relaxing muscle tension, reducing pain, and providing a mild stimulant effect to enhance pain relief.

Key Facts

Brand Name
Butalbital, Acetaminophen, Caffeine
Generic Name
Butalbital, Acetaminophen, and Caffeine
NDC Code (Product)
76420-802
Manufacturer
Asclemed USA, Inc.
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
ANDA209587
Drug Class
Barbiturate [EPC]; Central Nervous System Stimulant [EPC]
Marketing Start
03/05/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache177 reports
completed suicide166 reports
nausea143 reports
toxicity to various agents140 reports
drug ineffective131 reports
fatigue120 reports
pain119 reports
migraine104 reports
diarrhoea102 reports
dizziness85 reports

Frequently Asked Questions

What is Butalbital, Acetaminophen, Caffeine used for?

This is a prescription tablet containing a barbiturate combined with acetaminophen and caffeine, used to treat tension headaches and similar pain conditions. The combination works by relaxing muscle tension, reducing pain, and providing a mild stimulant effect to enhance pain relief.

Is Butalbital, Acetaminophen, Caffeine a controlled substance?

Yes, Butalbital, Acetaminophen, Caffeine is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Butalbital, Acetaminophen, Caffeine?

The generic name for Butalbital, Acetaminophen, Caffeine is Butalbital, Acetaminophen, and Caffeine. There are 6 other brand versions of Butalbital, Acetaminophen, and Caffeine.

What is the NDC code for Butalbital, Acetaminophen, Caffeine 325 mg/1?

The NDC (National Drug Code) for Butalbital, Acetaminophen, Caffeine 325 mg/1 is 76420-802, listed by Asclemed USA, Inc..

Product NDC

76420-802

Package NDC

76420-802-01

Other Butalbital, Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)