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NDC 51672-2116-02 Feverall 325 mg/1 Details
Feverall 325 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: 51672-2116-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal
Product Information
| NDC | 51672-2116 |
|---|---|
| Product ID | 51672-2116_fbd0c378-6d46-4f6f-b473-610dd4d20bb1 |
| Associated GPIs | 64200010005215 |
| GCN Sequence Number | 004477 |
| GCN Sequence Number Description | acetaminophen SUPP.RECT 325 MG RECTAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16905 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | Feverall |
| Proprietary Name Suffix | Jr. Strength |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUPPOSITORY |
| Route | RECTAL |
| Active Ingredient Strength | 325 |
| 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 51672-2116-02 (51672211602)
| NDC Package Code | 51672-2116-2 |
|---|---|
| Billing NDC | 51672211602 |
| Package | 6 BLISTER PACK in 1 CARTON (51672-2116-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2116-0) |
| Marketing Start Date | 2013-12-12 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.68639 |
| Pricing Unit | EA |
| Effective Date | 2022-09-21 |
| NDC Description | FEVERALL 325 MG SUPPOSITORY |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 3561bbc3-53b0-4857-8b71-39e165ed95ce Details
Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if
- a child 6 to 12 years takes more than 5 doses in 24 hours
- 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.
For rectal use only.
Do not use
- in children under 6 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.
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
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
| Age | Dose |
|---|---|
| under 6 years | do not use |
| 6 to 12 years | Use 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours) |
| adults and children 12 years and older | Use 2 suppositories every 4 to 6 hours. (maximum of 6 doses) |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton
INGREDIENTS AND APPEARANCE
| FEVERALL
JR. STRENGTH
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(51672-2116) | |
Revised: 7/2019
Document Id: fbd0c378-6d46-4f6f-b473-610dd4d20bb1
Set id: 3561bbc3-53b0-4857-8b71-39e165ed95ce
Version: 5
Effective Time: 20190726