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Medicines · US (FDA)

FDA 2001

FDA

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Approved 23 Mar 2001OralCapsule

The FDA lists this product in 8 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; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG

Strengths and forms

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

ACETAMINOPHEN 300MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA076560-002 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA076560-001 · Prescription
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA204649-001 · Discontinued
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleThis page
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA075929-001 · Discontinued
ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA215138-001 · 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 300MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA215138-002 · Prescription

ACETAMINOPHEN 325MG; BUTALBITAL 50MG; CAFFEINE 40MG; CODEINE PHOSPHATE 30MG · CapsuleANDA076528-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA075618.

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, Caffeine and Codeine Phosphate
Active substance: acetaminophen
Route: Oral
Dosage form: Capsule
Applicant: Hikma Intl Pharms
Status: Discontinued
FDA approval: 23 Mar 2001
Application: ANDA075618-001