Indications and uses
Temporarily - reduces fever - relieves minor aches, pains, and headache
Temporarily - reduces fever - relieves minor aches, pains, and headache
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
Drug Facts
Active Ingredient (in each rectal suppository)
Acetaminophen 650 mg
Pain reliever/fever reducer
Keep out of reach of children.
Temporarily - reduces fever - relieves minor aches, pains, and headache
If pregnant or breast-feeding, ask a health professional before use.
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.
WARNINGS:
For rectal use only
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
-an adult or child 12 years or 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
-if 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.
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
glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate
Store at Room Temperature 15-30 C (59-86 F)
TAMPER-EVIDENT: Individually sealed in foil for your protection.
Do not use if foil is torn or open.
Established since 1919, G&W Laboratories, Inc. is one of the largest manufacturers of quality suppositories in the United States. We take special care to ensure that all products are of the finest quality you can buy.
SATISFACTION GUARANTEED OR YOUR MONEY BACK FROM G&W
G & W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
Visit our website @
www.gwlabs.com
Questions? call 1-800-922-1038
G&W and ACEPHEN are trademarks owned by their respective owners.
Distributed by:
Cardinal Health
Dublin, OH 43017
L3299120-10218
L3299120-20218
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 7 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 7 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 7 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | 7 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 7 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | 7 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55154-8850 | 55154-8850-0 |
| 0713-0165 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| HYDROGENATED CASTOR OIL | ZF94AP8MEY | IACT |
| PEG-100 STEARATE | YD01N1999R | IACT |
| SORBITAN MONOOLEATE | 06XEA2VD56 | 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 |
|---|---|---|---|---|---|---|
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | GEL / TOPICAL | 20 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, DELAYED RELEASE / ORAL | 15 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | LIQUID / TOPICAL | 0.24 %w/w | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | LOTION / TOPICAL | 7 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | GRANULE, FOR SUSPENSION / ORAL | 4 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 23 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | OINTMENT / TOPICAL | NA | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, FILM COATED / ORAL | 17 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | CAPSULE / ORAL | 288 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, EXTENDED RELEASE / ORAL | 393 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SPRAY / TOPICAL | 8 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | CAPSULE / ORAL | 405 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET, COATED / ORAL | 0.13 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | CREAM / TOPICAL | 11000 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | CAPSULE, EXTENDED RELEASE / ORAL | 410.82 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET, FILM COATED / ORAL | 12 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | SUSPENSION / TOPICAL | 286 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | AEROSOL, FOAM / TOPICAL | 2 %w/w | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, DELAYED RELEASE / ORAL | 1337 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SUPPOSITORY / RECTAL | 390 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | TABLET / ORAL | 19 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET, FOR SUSPENSION / ORAL | 17 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SYSTEM / TRANSDERMAL | 2.33 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SOLUTION / ORAL | 1080 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET / SUBLINGUAL | 1.6 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | TABLET / ORAL | 232 mg | ||
| HYDROGENATED CASTOR OIL | HYDROGENATED CASTOR OIL | ZF94AP8MEY | CAPSULE, DELAYED RELEASE / ORAL | 3.1 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | EMULSION / TOPICAL | 34050 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 |
|---|---|---|---|---|---|---|---|
| A072237-001 | ACEPHEN | ACETAMINOPHEN | 650MG | SUPPOSITORY / RECTAL | 1992-03-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 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 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 |
|---|---|---|---|---|---|---|
| 2b03c3d4-74a3-418e-9dec-c367fa1effde | d0469b34-486f-451f-9319-48771df6857a | 2020-05-19 | Warnings | d0469b34-486f-451f-9319-48771df6857a |
Adverse event summaries are temporarily unavailable. Other product information remains available.