5427-Rugby

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains caused by

• headache

• muscular aches

• the common cold

• toothache

• backache

• minor pain of arthritis

• premenstrual and menstrual cramps

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

adults and children 12 years and over:

• take 2 tablets every 6 hours while symptoms last

• do not take more than 6 tablets 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

store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

SPL UNCLASSIFIED SECTION

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

*Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®.

Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268

Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL®*

NDC 0536-1172-01

Extra Strength Acetaminophen

500mg each

Pain Reliever/Fever Reducer

Aspirin Free

100 Tablets