Feverall ®

Feverall ®
SPL v7
SPL
SPL Set ID 3ade895b-5dca-4d81-9415-8091923162ff
Route
RECTAL
Published
Effective Date 2019-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Glyceryl Monostearate Hydrogenated Palm Kernel Oil Peg-100 Stearate Polysorbate 80

Identifiers & Packaging

Marketing Status
NDA Active Since 2013-12-12
Description

Drug Facts

Purpose

Pain reliever/fever reducer

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

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
  • 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)
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.
Questions?

call 1-866-923-4914

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
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
  • 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.

Active Ingredient (in Each Rectal Suppository)

Acetaminophen, USP 80 mg

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

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)

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
  • 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)
Do Not Use (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.
Questions?

call 1-866-923-4914

Liver Warning (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
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)
  • the child has liver disease.
  • the child is 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 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.

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

Acetaminophen, USP 80 mg

Principal Display Panel 6 Suppository Blister Pack Carton (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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:30.582475 · Updated: 2026-03-14T23:12:45.219834