acetaminophen

Manufacturer
A-S Medication Solutions
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 00:50:59

Label at a glance#

Productacetaminophen for children
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily • reduces fever • relieves minor aches, pains, and headache

Dosage and administration

• 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)

Storage and handling

• 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.

Label contents#

Full prescribing information#

Active ingredient (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 120 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily

  • reduces fever
  • relieves minor aches, pains, and headache

Warnings

WARNINGS SECTION

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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.

For rectal use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • your child has liver disease
  • your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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)

Other information

STORAGE AND HANDLING SECTION

  • 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.

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Acetaminophen For Children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198434acetaminophen 120 MG Rectal SuppositoryPSN22
198434acetaminophen 120 MG Rectal SuppositorySCD22
198434APAP 120 MG Rectal SuppositorySY22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0001-0acetaminophenfor children12 in 1 CARTONSUPPOSITORY1222
50090-0001-0acetaminophenfor children1 in 1 BLISTER PACKSUPPOSITORY122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0001ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [A-S MEDICATION SOLUTIONS]22Legacy NDC, 2 package rows20250108_a9864f73-abb2-4cb1-a692-a48efdeeedf8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0001-0EA - Each50090-000127d54e6b-65ef-4831-ab57-820a219dcc4c12018-08-13
45802-732-30EA - Each45802-732e8e1375a-1e68-4050-a5fe-ab9af8d2304e12012-07-24
45802-732-33EA - Each45802-7322042f506-8d51-4446-8d6e-4ea04cd9699012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
COTTONSEED OILINACTIVE INGREDIENTH3E878020N1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-000150090-0001-0
45802-732

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
COTTONSEED ACIDH3E878020NIACT

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
COTTONSEED OILCOTTONSEED OILH3E878020NSPRAY, METERED / NASAL1.33 mg/0.1mlExact identifier — unii candidate
5 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NINJECTION, SOLUTION / INTRAMUSCULAR1120 mgExact identifier — unii candidate
5 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NINJECTION / INTRAMUSCULAR1084 mgExact identifier — unii candidate
5 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NCAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
COTTONSEED OILCOTTONSEED OILH3E878020NTABLET / ORAL0.16 mgExact identifier — unii candidate
5 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070607-001ACETAMINOPHENACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063f01610625f2…
2019-09-15 20:21 UTC2019-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acetaminophen for childrenACETAMINOPHENA-S Medication Solutionsa9864f73-abb2-4cb1-a692-a48efdeeedf82025-01-06WarningsExact identifier
ndc (package): 50090-0001-0
ndc (product): 50090-0001
ndc11 (package): 50090000100
spl id: 6e24b96f-e845-4f44-beaa-b43d15baf413
spl set id: a9864f73-abb2-4cb1-a692-a48efdeeedf8
acetaminophen for childrenACETAMINOPHENPadagis Israel Pharmaceuticals Ltd62b3d354-d7f5-4ba0-b233-ea6be0d7ff032024-12-17WarningsExact identifier
ndc (product): 45802-732

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.