Medique @ Home APAP

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 325 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

■ adult takes more than 4,000 mg of acetaminophen in 24 hours

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 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 ifthe user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop using and ask a doctor if

■ pain gets worse or lasts more than 10 days in adults

■ pain gets worse or lasts more than 5 days in children under 12 years

■ 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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use more than directed (see overdose warning)

Adults and children 12 years and over ■ take 2 tablets every 4 to 6 hours while symptoms last ■ do not take more than 10 tablets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor

Children 6 years to under 12 years ■ take 1 tablet every 4 to 6 hours while symptoms last ■ do not take more than 5 tablets in 24 hours ■ do not use for more than 5 days unless directed by a doctor

Children under 6 years ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ TAMPER EVIDENT child resistant packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mediqque® @ Home

APAP Tablets

Acetaminophen 325 mg

Pain Reliever/Fever Reducer

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Tablets per Packet)

Compare to the active ingredient in Tylenol® Tablets