OTC - ACTIVE INGREDIENT SECTION
Acetaminophen USP 500mg
Acetaminophen Tablets extra strength
- Manufacturer
- Elysium Pharmaceuticals Ltd. | Elysium Pharmaceuticals Limited
- Effective date
- 2025-11-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:51:23
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
for further packing and labelling
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
keep out of reach of children
WARNINGS SECTION
keep out of reach of children and for further packing
INACTIVE INGREDIENT SECTION
Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone , Stearic Acid powder,Titanium Dioxide, Talc,
DOSAGE & ADMINISTRATION SECTION
anti-inflamatory and for further packing
INDICATIONS & USAGE SECTION
Anti Inflamatory
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- HYPROMELLOSES
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- STARCH, PREGELATINIZED CORN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- N-VINYLPYRROLIDINONE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 14803-281 | 14803-281-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| N-VINYLPYRROLIDINONE | 76H9G81541 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 44a372b0-69e7-21b5-e063-6294a90ab111 | 44a36fdb-23bc-2b67-e063-6294a90aa77b | 2025-11-27 | Warnings | 44a372b0-69e7-21b5-e063-6294a90ab111 44a36fdb-23bc-2b67-e063-6294a90aa77b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.