Indications and uses
temporarily • reduces fever • relieves minor aches, pains, and headache
temporarily • reduces fever • relieves minor aches, pains, and headache
• do not use more than directed • remove foil wrapper • insert suppository well up into rectum children under 6 years do not use children 6-12 years 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) adults and children 12 years and older 2 suppositories every 4 to 6 hours (maximum of 6 d...
Acetaminophen 325 mg
Pain reliever/fever reducer
temporarily
• reduces fever
• relieves minor aches, pains, and headache
For rectal use only
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if
• a child 6 to 12 years takes more than 5 doses in 24 hours
• an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• an adult takes 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
• in children under 6 years
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
• you have liver disease
• you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
• fever lasts more than 3 days (72 hours), or recurs
• new symptoms occur
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
• do not use more than directed
• remove foil wrapper
• insert suppository well up into rectum
| children under 6 years | do not use |
| children 6-12 years | 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
adults and children 12 years and older | 2 suppositories every 4 to 6 hours (maximum of 6 doses) |
• store at room temperature 15˚-30˚C (59˚-86˚F)
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
call 1-800-922-1038
CommUnityCare Federally Qualified Health Centers
Acetaminophen
325mg Supp.
Date:
Name:
Dr.
Hancock item only
123456
1/1/01
Acetaminophen 325mg Suppositories NDC 76413-302-12
Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABS
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 209360 | Acephen 325 MG Rectal Suppository | PSN | 1 |
| 198437 | acetaminophen 325 MG Rectal Suppository | PSN | 1 |
| 209360 | acetaminophen 325 MG Rectal Suppository [Acephen] | SBD | 1 |
| 198437 | acetaminophen 325 MG Rectal Suppository | SCD | 1 |
| 209360 | Acephen 325 MG Rectal Suppository | SY | 1 |
| 198437 | APAP 325 MG Rectal Suppository | SY | 1 |
| 209360 | APAP 325 MG Rectal Suppository [Acephen] | SY | 1 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-302-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0e82-f424-e053-dadaa90a57ce | Acephen TM Acetaminophen Suppositories USP 325 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-302-12 | ACEPHEN | 12 in 1 BOX | SUPPOSITORY | 12 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0164-01 | EA - Each | 0713-0164 | 3769ece4-dabc-468f-95af-d931029602c0 | 1 | 2012-07-24 |
| 0713-0164-12 | EA - Each | 0713-0164 | 7d019957-2e03-4445-9a21-531148fdf8d7 | 1 | 2012-07-24 |
| 0713-0164-50 | EA - Each | 0713-0164 | b3355a60-8554-478d-ae69-0b35e3124a37 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76413-302 | 76413-302-12 |
| 0713-0164 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Glyceryl Monostearate | 230OU9XXE4 | IACT |
| Hydrogenated Coconut Oil | JY81OXM1OM | IACT |
| Peg-100 Stearate | YD01N1999R | IACT |
| Sorbitan Monooleate | 06XEA2VD56 | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072344-001 | ACEPHEN | ACETAMINOPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072344-001 | ACEPHEN | 325MG | SUPPOSITORY / RECTAL | 1992-03-27 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 3516536e-4b3c-419f-a0e8-35e759fd7d14 | aa6314c7-e816-4bb5-811c-5975fce1f743 | 2016-03-09 | Warnings | 3516536e-4b3c-419f-a0e8-35e759fd7d14 aa6314c7-e816-4bb5-811c-5975fce1f743 |
Adverse event summaries are temporarily unavailable. Other product information remains available.