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NDC 51672-2114-04 Feverall 80 mg/1 Details

Feverall 80 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: 51672-2114-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	51672-2114
Product ID	51672-2114_3ab328f8-6389-44fd-bb84-8b28709dbc30
Associated GPIs	64200010005203
GCN Sequence Number	016943
GCN Sequence Number Description	acetaminophen SUPP.RECT 80 MG RECTAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16908
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Brand
Proprietary Name	Feverall
Proprietary Name Suffix	Infants
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	80
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 51672-2114-04 (51672211404)

Pricing Information
NDC Package Code	51672-2114-4
Billing NDC	51672211404
Package	50 BLISTER PACK in 1 CARTON (51672-2114-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0)
Marketing Start Date	2013-12-12
NDC Exclude Flag	N
Price Per Unit	0.69759
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	FEVERALL 80 MG SUPPOSITORY
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	B
As of Date	2024-02-21

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 3ade895b-5dca-4d81-9415-8091923162ff Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 80 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

reduces fever
relieves minor aches, pains, and headache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
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.

Stop use and ask a doctor if

fever lasts more than 3 days (72 hours), or recurs.
pain lasts more than 3 days or gets worse.
new symptoms occur.
redness or swelling is present in the painful area.

These may be signs of a serious condition.

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

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 6 months	Do not use unless directed by a doctor
6 to 11 months	Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours)
12 to 36 months	Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Other information

store at 2°-27°C (35°-80°F)
do not use if imprinted suppository wrapper is opened or damaged

Inactive ingredients

glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Dist. by: Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 6 Suppository Blister Pack Carton

NDC 51672-2114-2

RECTAL

SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

✓: No Parabens or Any Other Preservatives
✓: No Artificial Colors

INFANTS'

ages 6-36 months

FeverAll®

ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6

Rectal

Suppositories

80

mg

each

PRINCIPAL DISPLAY PANEL - 6 Suppository Blister Pack Carton

INGREDIENTS AND APPEARANCE

FEVERALL INFANTS

acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2114
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	80 mg

Ingredient Name	Strength
Inactive Ingredients
glyceryl monostearate (UNII: 230OU9XXE4)
hydrogenated palm kernel oil (UNII: FM8D1RE2VP)
PEG-100 stearate (UNII: YD01N1999R)
polysorbate 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2114-2	6 in 1 CARTON	12/12/2013
1	NDC:51672-2114-0	1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:51672-2114-4	50 in 1 CARTON	12/12/2013
2	NDC:51672-2114-0	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018337	12/12/2013

Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
G&W NC Laboratories, Inc.		079419931	MANUFACTURE(51672-2114)

Revised: 7/2019

Document Id: 3ab328f8-6389-44fd-bb84-8b28709dbc30

Set id: 3ade895b-5dca-4d81-9415-8091923162ff

Version: 5

Effective Time: 20190726

Search by Drug Name or NDC

NDC 51672-2114-04 Feverall 80 mg/1 Details

Feverall 80 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2114-04 (51672211404)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3ade895b-5dca-4d81-9415-8091923162ff Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each rectal suppository)

Purposes

Uses

Warnings

Liver warning

Do not use

Ask a doctor before use if

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 6 Suppository Blister Pack Carton

INGREDIENTS AND APPEARANCE

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