Feverall ®

Feverall ®
SPL v3
SPL
SPL Set ID 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0
Route
RECTAL
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

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
Description

Drug Facts

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen Suppositories 325 mg NDC 63629-8240-1: 12 Rectal Suppositories Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen Suppositories 325 mg

  • NDC 63629-8240-1: 12 Rectal Suppositories

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4

Acetaminophen Suppositories 325 mg



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

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.

Section 51945-4 (51945-4)

Acetaminophen Suppositories 325 mg



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

How Supplied (HOW SUPPLIED)

Acetaminophen Suppositories 325 mg

  • NDC 63629-8240-1: 12 Rectal Suppositories

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.386362 · Updated: 2026-03-14T23:07:39.601528