Drugplain

Butalbital, Acetaminophen, Caffeine 325 mg/1

Butalbital, Acetaminophen, and Caffeine · TABLET · Preferred Pharmaceuticals 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 medication works by relaxing muscle tension and reducing pain signals while the caffeine helps enhance the pain-relieving effects.

Key Facts

Brand Name
Butalbital, Acetaminophen, Caffeine
Generic Name
Butalbital, Acetaminophen, and Caffeine
NDC Code (Product)
68788-8137
Manufacturer
Preferred Pharmaceuticals 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
02/11/2022

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 medication works by relaxing muscle tension and reducing pain signals while the caffeine helps enhance the pain-relieving effects.

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 68788-8137, listed by Preferred Pharmaceuticals Inc..

Product NDC

68788-8137

Package NDC

68788-8137-2

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)