Indications and uses
temporarily reduces fever temporarily relieves minor aches, pains and headache
temporarily reduces fever temporarily relieves minor aches, pains and headache
do not use more than directed remove wrapper carefully insert suppository well up into the rectum adults and children 12 years and older: 1 suppository every 4 to 6 hours while symptoms last do not exceed 6 suppositories in any 24 hour period
Acetaminophen 650 mg
Pain reliever/fever reducer
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 for adults as well as for children even if you do not notice any signs or symptoms.
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
For rectal use only.
These could be signs of a serious condition.
Do not use if printed wrapper is open or damaged.
Glycerol Monostearate, Hydrogenated Vegetable Oil, Lecithin, Polysorbate 80
Call (609-695-4300)
Acino Products
NDC 68784-113-10
*Compare to the active ingredient in Fever All
For Adults
Acetaminophen Suppositories USP, 650 mg
Pain reliever/Fever reducer
Ages 12 and over
See New Warning
10 Rectal Suppositories 650 mg each
Tamper-evident: Suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND INFORMATION
Acino Products LLC
9B South Gold Drive
Hamilton, NJ 08691.
MADE IN THE USA
*This product is not manufactured or distributed by Acino Mid Atlantic LLC the distributed of Fever All®
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68784-113-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-809e-f424-e053-dadaa90a57ce | Acetaminophen Suppositories - 113 DPL |
| 68784-113-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-809e-f424-e053-dadaa90a57ce | Acetaminophen Suppositories - 113 DPL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68784-113-10 | ACETAMINOPHENFor Adults | 10 in 1 BOX | SUPPOSITORY | 10 | 1 | |
| 68784-113-50 | ACETAMINOPHENFor Adults | 50 in 1 BOX | SUPPOSITORY | 50 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68784-113 | 68784-113-10, 68784-113-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| FAT, HARD | 8334LX7S21 | IACT |
| HYDROGENATED SOYBEAN LECITHIN | H1109Z9J4N | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
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 |
|---|---|---|---|---|---|---|
| 4cdf03c7-e115-44f3-9cad-f4b934fac6de | 49ac0d42-9a30-4f99-84d4-1eb2a0cc849f | 2016-02-03 | Warnings | 4cdf03c7-e115-44f3-9cad-f4b934fac6de 49ac0d42-9a30-4f99-84d4-1eb2a0cc849f |
Adverse event summaries are temporarily unavailable. Other product information remains available.