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Medicines · US (FDA)
Opioids

FDA 1984

Anilides

Butalbital and Acetaminophen

Approved 19 Oct 1984OralTablet

The FDA lists this product in 15 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 325MG; BUTALBITAL 50MG

Strengths and forms

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

ACETAMINOPHEN 325MG; BUTALBITAL 50MG · TabletThis page
ACETAMINOPHEN 325MG; BUTALBITAL 50MG · TabletANDA205120-001 · Discontinued
ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA207635-001 · Discontinued
ACETAMINOPHEN 325MG; BUTALBITAL 50MG · TabletANDA203484-002 · Prescription
ACETAMINOPHEN 300MG; BUTALBITAL 50MG · CapsuleANDA213115-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG · TabletANDA214088-003 · Prescription
ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA214088-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 25MG · TabletANDA214088-002 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG · TabletANDA089568-001 · Discontinued

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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 325MG; BUTALBITAL 50MG · TabletANDA214291-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA214955-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA090956-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA207386-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG · CapsuleANDA207313-001 · Prescription

ACETAMINOPHEN 300MG; BUTALBITAL 50MG · TabletANDA214305-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA087550.

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 and Acetaminophen
Active substance: acetaminophen
Drug class: Anilides, Opioids in combination with non-opioid analgesics
Group: Opioids
Route: Oral
Dosage form: Tablet
Applicant: Watson Labs
Status: Discontinued
FDA approval: 19 Oct 1984
Application: ANDA087550-001
RxCUI: 161

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