Acetaminophen

Manufacturer: Rugby Laboratories | LNK International, Inc.
Effective date: 2025-10-22
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:41:30

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact1-800-426-9391

PhoneLabel contact(800) 616-2471

Websitewww.majorpharmaceuticals.com

www.majorpharmaceuticals.com

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day 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.

Do not use

OTC - DO NOT USE SECTION

if you are allergic to acetaminophen or any of the inactive ingredients in this product
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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
adults and children 12 years and over
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1413-48

Extra Strength
Acetaminophen
500 mg

Pain Reliever/Fever Reducer

Contains no aspirin

Actual size

Institutional Dispensing Only

100 Caplets
(50 pouches of 2 caplets each)

TAMPER EVIDENT: DO NOT USE IF
POUCH IS TORN OR OPEN

POUCH NOT FOR INDIVIDUAL SALE

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

50844 ORG062117524

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	2
198440	acetaminophen 500 MG Oral Tablet	SCD	2
198440	APAP 500 MG Oral Tablet	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1413-47	Acetaminophen	2 in 1 POUCH	TABLET, FILM COATED	2		2
0536-1413-48	Acetaminophen	50 in 1 CARTON	TABLET, FILM COATED	50		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1413-47	EA - Each	0536-1413	63900bc4-fb25-4121-a3e8-49177d2fc83f	1	2025-03-04
0536-1413-48	EA - Each	0536-1413	bd316c5c-ca83-4c2f-9581-6da0ced4685b	1	2025-03-04

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Acetaminophen
CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1413	0536-1413-47, 0536-1413-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2024-10-03	full-release	2026-06-01 00:22:32

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	b16ed4ef-689c-4df2-ab6c-207aa8b9925d	2025-10-22	Warnings	Exact identifier ndc (package): 0536-1413-47 ndc (package): 0536-1413-48 ndc (product): 0536-1413 ndc11 (package): 00536141347 ndc11 (package): 00536141348 spl id: c1c09905-1731-444f-9c1b-5cb995585f16 spl set id: b16ed4ef-689c-4df2-ab6c-207aa8b9925d

Reported adverse events (FAERS/openFDA)#

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