Feverall ®

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Glyceryl Monostearate Hydrogenated Palm Kernel Oil Peg-100 Stearate Polysorbate 80

Identifiers & Packaging

Marketing Status

NDA Active Since 2013-12-12

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily

reduces fever
relieves minor aches, pains, and headache

Section 42229-5

Drug Facts

Section 50565-1

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.

Purposes

Pain reliever/fever reducer

Directions

do not use more than directed
remove wrapper
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)

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.

Questions?

call 1-866-923-4914

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

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

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.

Active Ingredient (in Each Rectal Suppository)

Acetaminophen, USP 325 mg

Principal Display Panel 325 Mg Suppository Blister Pack Carton

NDC 51672-2116-2

RECTAL

SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

No Parabens or Any Other Preservatives
No Artificial Colors

JR. STRENGTH

ages 6-12 years

FeverAll _®

ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6

Rectal

Suppositories

325

mg

each

Structured Label Content

Uses

temporarily

reduces fever
relieves minor aches, pains, and headache

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purposes

Pain reliever/fever reducer

Directions

do not use more than directed
remove wrapper
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)

Do Not Use (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.

Questions?

call 1-866-923-4914

Liver Warning (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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use If (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 (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.

Active Ingredient (in Each Rectal Suppository) (Active ingredient (in each rectal suppository))

Acetaminophen, USP 325 mg

Principal Display Panel 325 Mg Suppository Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton)

NDC 51672-2116-2

RECTAL

SUPPOSITORY*

*actual size

Doctor Recommended

Pain Reliever/Fever Reducer

No Parabens or Any Other Preservatives
No Artificial Colors

JR. STRENGTH

ages 6-12 years

FeverAll _®

ACETAMINOPHEN SUPPOSITORIES

Pain Reliever/Fever Reducer

6

Rectal

Suppositories

325

mg

each

Advanced Ingredient Data

[{"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED PALM KERNEL OIL", "unii": "FM8D1RE2VP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily reduces fever relieves minor aches, pains, and headache", "42229-5": "Drug Facts", "50565-1": "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.", "Purposes": "Pain reliever/fever reducer", "Directions": "do not use more than directed remove wrapper 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)", "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.", "Questions?": "call 1-866-923-4914", "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", "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", "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.", "Active ingredient (in each rectal suppository)": "Acetaminophen, USP 325 mg", "PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton": "NDC 51672-2116-2 RECTAL SUPPOSITORY* *actual size Doctor Recommended Pain Reliever/Fever Reducer No Parabens or Any Other Preservatives No Artificial Colors JR. STRENGTH ages 6-12 years FeverAll ® ACETAMINOPHEN SUPPOSITORIES Pain Reliever/Fever Reducer 6 Rectal Suppositories 325 mg each"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information