Indications and uses
temporarily reduces fever relieves minor aches, pains, and headache
ACETAMINOPHEN
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2011-04-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:28:02
Label at a glance#
ProductACETAMINOPHEN pain reliever/fever reducer
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not use more than directed remove wrapper carefully insert suppository well up into the rectum adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last do not exceed 6 suppositories in any 24 hour period children under 12 years: ask a doctor
Storage and handling
tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged. store at 20°-25°C (68°-77°F) or in a cool place
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each rectal suppository)
Acetaminophen 650 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily
- reduces fever
- relieves minor aches, pains, and headache
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
- 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
For rectal use only
Do not use
- in children under 12 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.
- pain gets worse or lasts more than 10 days.
- new symptoms occur.
- 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. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
- adults and children 12 years and older:
- 1 suppository every 4 to 6 hours while symptoms last
- do not exceed 6 suppositories in any 24 hour period
- children under 12 years: ask a doctor
Other information
- tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
- store at 20°-25°C (68°-77°F) or in a cool place
Inactive ingredients
hydrogenated vegetable oil
Questions or comments?
1-800-719-9260
PRINCIPAL DISPLAY PANEL
Acetaminophen Suppositories USP, 650 mg
NDC 54868-4991-0
Pain Reliever/Fever Reducer
See New Warnings Information
Read and Keep Carton for New Liver Warning
650 mg Each
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-4991-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-48e6-c013-e053-90daa90a1393 | cddc841a-ab37-4480-a9d1-4764cba3ec80 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-4991-0 | ACETAMINOPHENpain reliever/fever reducer | 2 in 1 CARTON | SUPPOSITORY | 2 | 1 | |
| 54868-4991-0 | ACETAMINOPHENpain reliever/fever reducer | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-4991 | ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.] | 1 | 2 package rows | 20110517_cddc841a-ab37-4480-a9d1-4764cba3ec80.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-4991-0 | EA - Each | 54868-4991 | 1cd3395f-4c41-4214-bb94-1b40d9baeb31 | 1 | 2012-07-24 |
| 45802-730-00 | EA - Each | 45802-730 | 3c5924a3-7481-46b6-b02f-32490b82f244 | 1 | 2017-09-11 |
| 45802-730-30 | EA - Each | 45802-730 | 4eb304ff-ffb0-4674-89aa-a85f27881294 | 1 | 2012-07-24 |
| 45802-730-32 | EA - Each | 45802-730 | 981014ad-d51a-48bd-a0aa-70d4209cf284 | 1 | 2012-07-24 |
| 45802-730-33 | EA - Each | 45802-730 | d672d7a1-16aa-4aea-aa1d-91d28743bda7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| HYDROGENATED PALM KERNEL OIL | INACTIVE INGREDIENT | FM8D1RE2VP | 1 |
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN pain reliever/fever reducer
- acetaminophen
- HYDROGENATED PALM KERNEL OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54868-4991 | 54868-4991-0 |
| 45802-730 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| HYDROGENATED PALM KERNEL OIL | FM8D1RE2VP | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070608-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 |
Observed Orange Book product history#
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 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070608-001 | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1986-12-01 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| acetaminophen pain reliever fever reducer | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | b43974c3-4db9-4201-beee-b22596a2b241 | 2025-02-12 | Warnings | 45802-730 |
| 3ea83636-fc0a-4085-8693-f0f1947b5454 | cddc841a-ab37-4480-a9d1-4764cba3ec80 | 2011-04-13 | Warnings | 3ea83636-fc0a-4085-8693-f0f1947b5454 cddc841a-ab37-4480-a9d1-4764cba3ec80 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.