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Pain Reliever Plus

acetaminophen, aspirin, caffeine · Pain Reliever Plus is a central nervous system stimulant (over-the-counter) containing acetaminophen, aspirin, caffeine, made by Rugby Laboratories.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
1

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

Drug facts

Generic name
acetaminophen, aspirin, caffeine
Active ingredients
Acetaminophen, Aspirin, Caffeine
How it works
Cyclooxygenase Inhibitors
Dosage forms
Tablet, film coated
Label holder
Rugby Laboratories
FDA application
M013
Label updated
07/07/2026

Active ingredients

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

Purpose

Pain reliever Pain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • A cold
  • Arthritis
  • Toothache
  • Premenstrual and menstrual cramps

Directions

  • 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

Warnings

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. 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. 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 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 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. 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. Keep out of reach of children. 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.

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.

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

Ask a doctor or pharmacist before use

  • Taking a prescription drug for diabetes, gout, or arthritis
  • Taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor

  • 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.

Pregnancy or breastfeeding

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.

Keep out of reach of children

Keep out of reach of children.

Overdose

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.

Inactive ingredients

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

Questions?

(800) 231-4670

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Tablet, film coated250 mg / 65 mg / 250 mgoral1

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $0.0633 per tablet, capsule or unit across 1 package code.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Manufacturers and labels

1 FDA label

  • Rugby LaboratoriesShown hereM013 · Label 07/07/2026 · NDC 0536-1326Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Pain Reliever Plus: common questions

What is Pain Reliever Plus used for?
■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ a cold ■ arthritis ■ toothache ■ premenstrual and menstrual cramps
Is Pain Reliever Plus a prescription drug?
No. Pain Reliever Plus is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Pain Reliever Plus?
Yes. Other FDA-listed products with the same active ingredients include Headache Relief Extra Strength, Headache Relief, Acetaminophen, Aspirin and Caffeine, Headache Relief Extra Strength.
Who makes Pain Reliever Plus?
Rugby Laboratories lists Pain Reliever Plus with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/07/2026 · Label text is shown as published by the manufacturer. Not medical advice