ACEPHEN

Manufacturer
Central Texas Community Health Centers
Effective date
2016-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:23

Label at a glance#

ProductACEPHEN
Active ingredientAcetaminophen
Label structure9 sections

Indications and uses

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

Dosage and administration

• 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...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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)

Other Information

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• store at room temperature 15˚-30˚C (59˚-86˚F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-922-1038

PRINCIPAL DISPLAY PANEL - 325 mg Suppository Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Principal Display Panel - 325 mg Suppository Box Label
Principal Display Panel - 325 mg Suppository Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209360Acephen 325 MG Rectal SuppositoryPSN1
198437acetaminophen 325 MG Rectal SuppositoryPSN1
209360acetaminophen 325 MG Rectal Suppository [Acephen]SBD1
198437acetaminophen 325 MG Rectal SuppositorySCD1
209360Acephen 325 MG Rectal SuppositorySY1
198437APAP 325 MG Rectal SuppositorySY1
209360APAP 325 MG Rectal Suppository [Acephen]SY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-302-122020-01-31C16284748780-19d75b9d1-0e82-f424-e053-dadaa90a57ceAcephen TM Acetaminophen Suppositories USP 325 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-302-12ACEPHEN12 in 1 BOXSUPPOSITORY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-302ACEPHEN (ACETAMINOPHEN) SUPPOSITORY [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20160310_aa6314c7-e816-4bb5-811c-5975fce1f743.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0164-01EA - Each0713-01643769ece4-dabc-468f-95af-d931029602c012012-07-24
0713-0164-12EA - Each0713-01647d019957-2e03-4445-9a21-531148fdf8d712012-07-24
0713-0164-50EA - Each0713-0164b3355a60-8554-478d-ae69-0b35e3124a3712012-07-24

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76413-30276413-302-12
0713-0164

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

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 44.

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
A072344-001ACEPHENACETAMINOPHEN325MGSUPPOSITORY / RECTAL1992-03-27

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27c2088c7a36db…
2026-09-14 22:38:342026-08A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-273f01610625f2…
2019-09-15 20:21 UTC2019-09A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072344-001ACEPHEN325MGSUPPOSITORY / RECTAL1992-03-273a93d1ddd44b…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3516536e-4b3c-419f-a0e8-35e759fd7d14aa6314c7-e816-4bb5-811c-5975fce1f7432016-03-09WarningsExact identifier
spl id: 3516536e-4b3c-419f-a0e8-35e759fd7d14
spl set id: aa6314c7-e816-4bb5-811c-5975fce1f743

Reported adverse events (FAERS/openFDA)#

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