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NDC 51672-2115-02 Feverall 120 mg/1 Details
Feverall 120 mg/1
Feverall is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A. Inc.. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen rectal is used to relieve mild to moderate pain from headaches or muscle aches and to reduce a fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 51672-2115-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal
Product Information
| NDC | 51672-2115 |
|---|---|
| Product ID | 51672-2115_f78b5761-ee3c-4a98-b152-cd0d2b08faa9 |
| Associated GPIs | 64200010005205 |
| GCN Sequence Number | 004475 |
| GCN Sequence Number Description | acetaminophen SUPP.RECT 120 MG RECTAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16903 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | Feverall |
| Proprietary Name Suffix | Childrens |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Taro Pharmaceuticals U.S.A. Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018337 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51672-2115-02 (51672211502)
| NDC Package Code | 51672-2115-2 |
|---|---|
| Billing NDC | 51672211502 |
| Package | 6 BLISTER PACK in 1 CARTON (51672-2115-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) |
| Marketing Start Date | 2013-12-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 861e2987-5473-45b0-b2a6-f980a9b0e809 Details
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
- 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
- the child has liver disease.
- the child is taking the blood thinning drug warfarin.
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
| Age | Dose |
|---|---|
| under 3 years | Do not use unless directed by a doctor |
| 3 to 6 years | Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton
INGREDIENTS AND APPEARANCE
| FEVERALL
CHILDRENS
acetaminophen suppository |
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| Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| G&W NC Laboratories, Inc. | 079419931 | MANUFACTURE(51672-2115) | |
Revised: 7/2019
Document Id: f78b5761-ee3c-4a98-b152-cd0d2b08faa9
Set id: 861e2987-5473-45b0-b2a6-f980a9b0e809
Version: 5
Effective Time: 20190726