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Medicines · US (FDA)

FDA 2022

FDA

Butalbital, Acetaminophen and Caffeine

Approved 25 Mar 2022OralCapsule

The FDA lists this product in 47 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CapsuleANDA088825-001 · Discontinued
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA204733-001 · Prescription
ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA215047-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA212083-001 · Prescription
ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA213046-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA214287-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040511-001 · Prescription

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040513-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040864-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA087804-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA204984-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA215135-002 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleThis page

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA211106-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA212082-001 · Prescription

ACETAMINOPHEN 325MG/15ML; BUTALBITAL 50MG/15ML; CAFFEINE 40MG/15ML · SolutionANDA040387-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA040885-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA087629-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA089067-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA203647-001 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA206615-001 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA214288-001 · Prescription

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA040261-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA200243-001 · Prescription

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040883-001 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA207118-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA209587-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA089536-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA089718-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA211543-001 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA213321-001 · Prescription

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040336-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040390-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040601-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA088616-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA088743-001 · Discontinued

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA210817-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA214087-002 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA214087-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA216376-001 · Prescription

ACETAMINOPHEN 750MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040496-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA088758-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA088765-001 · Discontinued

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · CapsuleANDA089007-001 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA089175-001 · Prescription

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040267-001 · Discontinued

ACETAMINOPHEN 500MG; BUTALBITAL 50MG; CAFFEINE 40MG · TabletANDA040394-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA215135.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Butalbital, Acetaminophen and Caffeine
Active substance: acetaminophen
Route: Oral
Dosage form: Capsule
Applicant: Hikma
Status: Discontinued
FDA approval: 25 Mar 2022
Application: ANDA215135-001