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NDC 63629-8240-01 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 Bryant Ranch Prepack. 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: 63629-8240-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal

Product Information

NDC	63629-8240
Product ID	63629-8240_302b4f3b-6f8a-410d-8e3d-19c72be2276b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA018337
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63629-8240-01 (63629824001)

Pricing Information	N/A
NDC Package Code	63629-8240-1
Billing NDC	63629824001
Package	12 SUPPOSITORY in 1 BOTTLE (63629-8240-1)
Marketing Start Date	2019-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each rectal suppository)

Acetaminophen, USP 325 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

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 everyday 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.

Ask a doctor before use if

you have liver disease.
you are taking the blood thinning drug warfarin.

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

remove wrapper
do not use more than directed
carefully insert suppository well up into the rectum

Dosing Chart
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

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

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

HOW SUPPLIED

Product: 63629-8240

NDC: 63629-8240-1 12 SUPPOSITORY in a BOTTLE

Acetaminophen Supp. 325mg Blister Pack

INGREDIENTS AND APPEARANCE

FEVERALL JR. STRENGTH

acetaminophen suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-8240(NDC:51672-2116)
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 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	Marketing End Date
Packaging
1	NDC:63629-8240-1	12 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2019

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

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-8240) , RELABEL(63629-8240)

Revised: 10/2019

Document Id: 302b4f3b-6f8a-410d-8e3d-19c72be2276b

Set id: 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0

Version: 1

Effective Time: 20191001

Search by Drug Name or NDC

NDC 63629-8240-01 Feverall 325 mg/1 Details

Feverall 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63629-8240-01 (63629824001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0 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

HOW SUPPLIED

Acetaminophen Supp. 325mg Blister Pack

INGREDIENTS AND APPEARANCE

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