FDA
Tylenol W/ Codeine No. 3
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG · TabletANDA085055-003 · Discontinued
- ACETAMINOPHEN 300MG; CODEINE PHOSPHATE 30MG · CapsuleThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA087422.
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
- Tylenol W/ Codeine No. 3
- Active substance
- acetaminophen
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Ortho Mcneil Pharm
- Status
- Discontinued
- FDA approval
- 29 Sept 1981
- Application
- ANDA087422-001