acetaminophen

Manufacturer: NuCare Pharmaceutiacals,Inc. | NuCare Pharmaceuticals,Inc.
Effective date: 2024-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:13:21

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.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198434	acetaminophen 120 MG Rectal Suppository	PSN	6
198434	acetaminophen 120 MG Rectal Suppository	SCD	6
198434	APAP 120 MG Rectal Suppository	SY	6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4151-1	2024-06-04	C162847	48780-1	ba0f9c33-43dd-a910-e053-dadaa90a0b85	Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts
68071-4151-1	2023-01-30	C162847	48780-1	ba0f9c33-43dd-a910-e053-dadaa90a0b85	Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts
68071-4151-1	2021-02-10	C162847	48780-1	ba0f9c33-43dd-a910-e053-dadaa90a0b85	Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts
68071-4151-1	2021-01-29	C162847	48780-1	ba0f9c33-43dd-a910-e053-dadaa90a0b85	Perrigo Acetaminophen Suppositories USP, 120 mg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4151-1	acetaminophenfor children	12 in 1 BOX	SUPPOSITORY	12		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4151	ACETAMINOPHEN FOR CHILDREN (ACETAMINOPHEN) SUPPOSITORY [NUCARE PHARMACEUTIACALS,INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240606_5d7ef1d2-d970-7b01-e053-2991aa0a1311.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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

Products#

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

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

acetaminophen for children
Acetaminophen
COTTONSEED OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-4151	68071-4151-1
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
Name	UNII	Kind
COTTONSEED OIL	H3E878020N	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML

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-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 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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acetaminophen for children	ACETAMINOPHEN	Padagis Israel Pharmaceuticals Ltd	62b3d354-d7f5-4ba0-b233-ea6be0d7ff03	2024-12-17	Warnings	Exact identifier ndc (product): 45802-732
acetaminophen for children	ACETAMINOPHEN	NuCare Pharmaceutiacals,Inc.	5d7ef1d2-d970-7b01-e053-2991aa0a1311	2024-06-04	Warnings	Exact identifier ndc (package): 68071-4151-1 ndc (product): 68071-4151 ndc11 (package): 68071415101 spl id: 1a15bc38-9384-1ded-e063-6394a90a647d spl set id: 5d7ef1d2-d970-7b01-e053-2991aa0a1311

Reported adverse events (FAERS/openFDA)#

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