Acetaminophen ER 650 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (In each caplet)

OTC - PURPOSE SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650mg ....................... Pain reliever/fever reducer.

Uses

• temporarily relieves minor aches and pain due to:
• muscular aches
• backache
• minor pain of arthritis
• toothache
• premenstrual and menstrual cramps
• headache
• the common cold
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

• more than 6 caplets 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.

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). 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.

Stop use and ask a doctor if

These could be signs of a serious condition.

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling if present.

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 Poision Control of 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 of symptoms.

Directions

Adults and children 12 years and over:

Children under 12 years:

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

Other information

• store between 20-25°C (68-77°F)
• do not use if foil inner seal imprinted with "SAFETY SEAL" is broken or missing.

Inactive ingredients

hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.