Acetaminophen 500 mg
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each tablet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever / fever reducer
INDICATIONS & USAGE SECTION
Uses
temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg in 24 hours, which is the maximum daily amount
■ 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.
OTC - DO NOT USE SECTION
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 using and ask a doctor if
■ pain gets worse or lasts more than for 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 - 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.
DOSAGE & ADMINISTRATION SECTION
Directions
■ do not use 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 use for more than 10 days unless directed by a doctor
Children under 12 years
Ask a doctor
OTHER SAFETY INFORMATION
Other information
■ store at room temperature 59º-86ºF (15º-30ºC)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*, purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
* May contain
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique
Extra Strength APAP
Non-Aspirin Tablets
THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.
Pain Reliever / Fever Reducer • Acetaminophen 500 mg
Compare active ingredient to Tylenol®
Registered McNeil Products
Tamper Evident Unit Dose Packets
24 Tablets
(12 x 2)