Pain Reliever Plus - Rugby Laboratories

Manufacturer
Rugby Laboratories
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-11 01:01:28

Label at a glance#

ProductPain Reliever Plus
Active ingredientASPIRIN, CAFFEINE, ACETAMINOPHEN
Label structure10 sections

Indications and uses

■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps

Dosage and administration

■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over: ■ take 2 caplets every 6 hours ■ do not take more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever
Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves minor aches and pains due to:
■ headache

■ muscular aches

■ a cold

■ arthritis
■ toothache

■ premenstrual and menstrual cramps

WARNINGS SECTION

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these
symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 3 or more alcoholic drinks every day while
using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: ■ are age 60 or older ■ take more or for a longer time than directed ■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ have 3 or more alcoholic drinks every day while using this product
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

OTC - DO NOT USE SECTION

Do not use

■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

■ you have liver disease
■ stomach bleeding warning applies to you

■ you have a history of stomach problems, such as heartburn

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you have asthma

■ you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding:

■ feel faint

■ have bloody or black stools

■ vomit blood

■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.
■ ringing in the ears or loss of hearing occurs

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ painful area is red or swollen

■ any new symptoms appear.
These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 use more than directed
■ drink a full glass of water with each dose
■ adults and children 12 years and over:
■ take 2 caplets every 6 hours
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

■ Store in a dry place at 15° – 30°C (59° – 86°F)

■ use by expiration date on package

INACTIVE INGREDIENT SECTION

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Questions or comments?

OTC - QUESTIONS SECTION

(800) 231-4670

SPL UNCLASSIFIED SECTION

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

DISTRIBUTED BY: RUGBY® LABORATORIES
INDIANAPOLIS, IN 46268
(800) 616-2471 www.majorpharmaceuticals.com

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Rev. 11/23 R-29 Re-order No. 302611

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby

Pain Reliever Plus

NDC 0536-1326-01
Compare to the active ingredients in Excedrin® Extra Strength Caplets†

Acetaminophen, Aspirin (NSAID)* and Caffeine

250mg/250mg/65mg

Pain Reliever/Pain Reliever Aid

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

100 Caplets

Rugby LabelRugby Label

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1326-01EA - Each0536-13260d809eff-8115-4130-a21f-1cebfd60ea3812021-07-15

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-13260536-1326-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-05-08full-release2026-06-01 00:12:15

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
ndc (package): 0536-1326-01
ndc (product): 0536-1326
ndc11 (package): 00536132601
spl id: 5608e9f5-edff-e748-e063-6394a90ae21b
spl set id: c3df1652-96a8-6043-e053-2995a90a2d26

Reported adverse events (FAERS/openFDA)#

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