Indications and uses
temporarily reduces fever temporarily relieves minor aches, pains and headache
ACETAMINOPHEN
- Manufacturer
- Acino Products, LLC
- Effective date
- 2016-02-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:52
Label at a glance#
ProductACETAMINOPHEN For Children
Active ingredientACETAMINOPHEN
Label structure13 sections
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 3 to 6 years Do not use unless directed by a doctor Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Contacts and useful links#
Label contents#
Full prescribing information#
Drug FactsActive ingredient (in each rectal suppository)
Acetaminophen 120 mg
Purpose
Pain reliever/fever reducer
Keep out of reach of children.
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.
Uses
- temporarily reduces fever
- temporarily relieves minor aches, pains and headache
Warnings
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
- 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
- your child has liver disease
- your child is taking the blood thinning drug warfarin
Stop use and ask a doctor if
- 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 could be signs of a serious condition.
Directions
- 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 3 to 6 years | Do not use unless directed by a doctor Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
Other information
- store at 20°-25°C (68°-77°F)
- tamper evident suppositories are individually wraped.
Do not use if printed wrapper is open or damaged.
Inactive ingredients
Glycerol Monostearate, Hydrogenated Vegetable Oil, Lecithin, Polysorbate 80
Questions or comments?
Call (609-695-4300)
Acetaminophen Suppositories For Children product label
Acion Products
NDC 68784-112-10
*Compare to the active ingredient in Fever All
For Children
Acetaminophen Suppositories USP, 120 mg
Pain reliever/Fever reducer
Age 3-6
See New Warning
10 Rectal Suppositories 120 mg each
Tamper-evident: Suppositories are individually wrapped. Do not use if printed wrapper is open 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®
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68784-112-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0405-f424-e053-dadaa90a57ce | Acetaminophen Suppositories - 112 DPL |
| 68784-112-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0405-f424-e053-dadaa90a57ce | Acetaminophen Suppositories - 112 DPL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68784-112-10 | ACETAMINOPHENFor Children | 10 in 1 BOX | SUPPOSITORY | 10 | 1 | |
| 68784-112-50 | ACETAMINOPHENFor Children | 50 in 1 BOX | SUPPOSITORY | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ACETAMINOPHEN For Children
- ACETAMINOPHEN
- GLYCERYL MONOSTEARATE
- FAT, HARD
- HYDROGENATED SOYBEAN LECITHIN
- POLYSORBATE 80
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68784-112 | 68784-112-10, 68784-112-50 |
Ingredients#
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 |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| cef5fab7-bc9e-47ef-aa33-7281e450d5cd | 4f9587bf-cc51-4cb3-8074-eaba3b60b298 | 2016-02-02 | Warnings | cef5fab7-bc9e-47ef-aa33-7281e450d5cd 4f9587bf-cc51-4cb3-8074-eaba3b60b298 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.