ACEPHEN

Manufacturer: Cosette Pharmaceuticals, Inc.
Effective date: 2022-04-20
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:02:12

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 • carefully insert suppository well up into rectum • adults and children 12 years and older • 1 suppository every 4 to 6 hours while symptoms persist • do not exceed 6 doses in any 24-hour period • children under 12 years: do not use

Contacts and useful links#

PhoneLabel contact1-800-922-1038

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 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
• 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 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. 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
• carefully insert suppository well up into rectum
• adults and children 12 years and older
• 1 suppository every 4 to 6 hours while symptoms persist
• do not exceed 6 doses in any 24-hour period
• children under 12 years: do not use

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0165-01
G&W ACEPHEN ^TMAcetaminophen Suppositories USP 650 mg
Pain Reliever • Fever Reducer
100 Rectal Suppositories

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0165-01	EA - Each	0713-0165	359cbefd-b75c-4d2e-98cb-8090c9e4c30b	1	2012-07-24
0713-0165-05	EA - Each	0713-0165	2bca9826-7584-4523-b05f-132f277ff31b	1	2012-07-24
0713-0165-10	EA - Each	0713-0165	eb8ada0e-5d82-4056-a67b-49d0822797df	1	2012-07-24
0713-0165-12	EA - Each	0713-0165	4480c92c-641f-4032-9ec6-c865b0e9f96f	1	2012-07-24
0713-0165-50	EA - Each	0713-0165	c0bce563-0361-41ff-a98a-ebe775017327	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	2
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	2
Hydrogenated Coconut Oil	INACTIVE INGREDIENT	JY81OXM1OM	2
Peg-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	2
Sorbitan Monooleate	INACTIVE INGREDIENT	06XEA2VD56	2

Products#

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

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

ACEPHEN
Acetaminophen
GLYCERYL MONOSTEARATE
HYDROGENATED COCONUT OIL
PEG-100 STEARATE
SORBITAN MONOOLEATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0713-0165	0713-0165-12, 0713-0165-01, 0713-0165-50, 0713-0165-10, 0713-0165-05

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROGENATED COCONUT OIL	JY81OXM1OM	IACT
PEG-100 STEARATE	YD01N1999R	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML · Source PDF

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 · 41 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, COATED / ORAL	0.13 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Peg-100 Stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / TOPICAL		552 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	CAPSULE / ORAL		288 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	SPRAY / TOPICAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	EMULSION / TOPICAL		34050 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	LOTION / TOPICAL		7 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Peg-100 Stearate	PEG-100 MONOSTEARATE	YD01N1999R	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	SUPPOSITORY / RECTAL		390 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Peg-100 Stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	SOLUTION / ORAL		1080 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
Hydrogenated Coconut Oil	HYDROGENATED COCONUT OIL	JY81OXM1OM	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, DELAYED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	CREAM / TOPICAL		11000 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	SYSTEM / TRANSDERMAL	2.33 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET / ORAL		19 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Sorbitan Monooleate	SORBITAN MONOOLEATE	06XEA2VD56	TABLET, FILM COATED / ORAL		12 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 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 44.

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
A072237-001	ACEPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL			1992-03-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072237-001	ACEPHEN	650MG	SUPPOSITORY / RECTAL	1992-03-27	`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.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
dd1b0d7c-51ad-cd10-e053-2995a90af3a5			ab9a9048-75b7-904c-6683-06d7de69ec52	2022-04-20	Warnings	Exact identifier spl id: dd1b0d7c-51ad-cd10-e053-2995a90af3a5 spl set id: ab9a9048-75b7-904c-6683-06d7de69ec52

Reported adverse events (FAERS/openFDA)#

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