FDA
Tylenol W/ Codeine
The FDA lists this product in 5 strengths and forms.
Composition
- Active ingredients
- ACETAMINOPHEN 325MG; CODEINE PHOSPHATE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ACETAMINOPHEN 325MG; CODEINE PHOSPHATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletANDA085056-003 · Discontinued
- ACETAMINOPHEN 325MG; CODEINE PHOSPHATE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletANDA085056-001 · Discontinued
- ACETAMINOPHEN 325MG; CODEINE PHOSPHATE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- ACETAMINOPHEN 325MG; CODEINE PHOSPHATE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletANDA085056-002 · Discontinued
- ACETAMINOPHEN 120MG/5ML; CODEINE PHOSPHATE 12MG/5ML · SolutionANDA085057-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA085056.
At a glance
- Brand name
- Tylenol W/ Codeine
- Active substance
- acetaminophen
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Ortho Mcneil Pharm
- Status
- Discontinued
- FDA approval
- 9 Jul 1976
- Application
- ANDA085056-004