Feverall

Manufacturer: Bryant Ranch Prepack
Effective date: 2025-01-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 20:41:08

Label at a glance#

ProductFeverall Jr. Strength

Active ingredientACETAMINOPHEN

Label structure12 sections

Indications and uses

temporarily reduces fever relieves minor aches, pains, and headache

Dosage and administration

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)

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each rectal suppository)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 325 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily

reduces fever
relieves minor aches, pains, and headache

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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)

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

HOW SUPPLIED

How Supplied Section

Acetaminophen Suppositories 325 mg

NDC 63629-8240-1: 12 Rectal Suppositories

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Suppositories 325 mg

Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8240	FEVERALL JR. STRENGTH (ACETAMINOPHEN) SUPPOSITORY [BRYANT RANCH PREPACK]	3	Legacy NDC	20250223_3f2cb4d8-64f8-42cd-91df-cd97480ee5f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-2116-2	EA - Each	51672-2116	fe61d879-44ce-47fd-bdf9-0adaffd7ae79	1	2014-09-03
51672-2116-4	EA - Each	51672-2116	8714140c-e1ea-469e-935e-2209831099f2	1	2014-09-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Feverall Jr. Strength
Acetaminophen
GLYCERYL MONOSTEARATE
HYDROGENATED PALM KERNEL OIL
PEG-100 STEARATE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63629-8240	63629-8240-1
51672-2116

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
HYDROGENATED PALM KERNEL OIL	FM8D1RE2VP	IACT
PEG-100 STEARATE	YD01N1999R	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018337-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N018337-002	ACETAMINOPHEN	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N018337-003	ACETAMINOPHEN	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12
N018337-004	INFANTS' FEVERALL	ACETAMINOPHEN	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018337-001	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018337-001	ACETAMINOPHEN	650MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-001	ACETAMINOPHEN	650MG	SUPPOSITORY / RECTAL	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-002	ACETAMINOPHEN	325MG	SUPPOSITORY / RECTAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-003	ACETAMINOPHEN	120MG	SUPPOSITORY / RECTAL	RLD	1983-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018337-004	INFANTS' FEVERALL	80MG	SUPPOSITORY / RECTAL	RLD	1992-08-26	`5bbf6a4d5a75…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Feverall Jr. Strength	ACETAMINOPHEN	Sun Pharmaceutical Industries, Inc.	3561bbc3-53b0-4857-8b71-39e165ed95ce	2026-09-03	Warnings	Exact identifier ndc (product): 51672-2116
eb921383-c42c-408e-9341-9ac7d4025476			3f2cb4d8-64f8-42cd-91df-cd97480ee5f0	2026-04-07	Warnings	Exact identifier spl set id: 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.