Indications and uses
temporarily • reduces fever • relieves minor aches, pains, and headache
temporarily • reduces fever • relieves minor aches, pains, and headache
• this product does not contain directions or warnings for adult use • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
• store at 20-25 ° C (68-77 ° F) or in a cool place • tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
Acetaminophen 120 mg
Pain reliever/fever reducer
temporarily
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
For rectal use only
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.
Dosing Chart | |
Age | Dose |
under 3 years | Do not use unless directed by a doctor |
3 to 6 years | Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
hydrogenated vegetable oil
1-800-719-9260
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0001-0 | acetaminophenfor children | 12 in 1 CARTON | SUPPOSITORY | 12 | 22 | |
| 50090-0001-0 | acetaminophenfor children | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | 22 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0001 | ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS] | 22 | Legacy NDC, 2 package rows | 20250108_a9864f73-abb2-4cb1-a692-a48efdeeedf8.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0001-0 | EA - Each | 50090-0001 | 27d54e6b-65ef-4831-ab57-820a219dcc4c | 1 | 2018-08-13 |
| 45802-732-30 | EA - Each | 45802-732 | e8e1375a-1e68-4050-a5fe-ab9af8d2304e | 1 | 2012-07-24 |
| 45802-732-33 | EA - Each | 45802-732 | 2042f506-8d51-4446-8d6e-4ea04cd96990 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| COTTONSEED OIL | INACTIVE INGREDIENT | H3E878020N | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-0001 | 50090-0001-0 |
| 45802-732 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| COTTONSEED ACID | H3E878020N | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | SPRAY, METERED / NASAL | 1.33 mg/0.1ml | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION, SOLUTION / INTRAMUSCULAR | 1120 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | INJECTION / INTRAMUSCULAR | 1084 mg | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | CAPSULE / ORAL | NA | ||
| COTTONSEED OIL | COTTONSEED OIL | H3E878020N | TABLET / ORAL | 0.16 mg |
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 |
|---|---|---|---|---|---|---|---|
| A070607-001 | ACETAMINOPHEN | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A070607-001 | ACETAMINOPHEN | 120MG | SUPPOSITORY / RECTAL | 1987-04-06 | f41ea6bd6efb… |
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 for children | ACETAMINOPHEN | A-S Medication Solutions | a9864f73-abb2-4cb1-a692-a48efdeeedf8 | 2025-01-06 | Warnings | 50090-0001-0 50090-0001 50090000100 6e24b96f-e845-4f44-beaa-b43d15baf413 a9864f73-abb2-4cb1-a692-a48efdeeedf8 |
| acetaminophen for children | ACETAMINOPHEN | Padagis Israel Pharmaceuticals Ltd | 62b3d354-d7f5-4ba0-b233-ea6be0d7ff03 | 2024-12-17 | Warnings | 45802-732 |
Adverse event summaries are temporarily unavailable. Other product information remains available.