FDA Label for Acetaminophen Caplets

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

_ temporarily relieves minor aches and pains due to:

_ headache _ the common cold

_ backache _ minor pain of arthritis

_ toothache _ muscular aches

_ premenstrual and menstrual cramps

_ temporarily reduces fever

Drug Facts (continued)

Warnings

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: _ rash _ blisters

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

Do Not Use

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

_ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

Drug Facts (continued)

contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use

if you have liver disease.

Ask A Doctor Or Pharmacist Before Use

if you are taking the blood thinning drug warfarin.

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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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

Drug Facts (continued)

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

_ adults and children 12 years and over

_ take 2 caplets every 6 hours while symptoms last

_ do not take more than 6 caplets 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 at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

_ use by expiration date on package

Drug Facts (continued)

Inactive Ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments?

1-800-901-2420

Dist. by Breeden Brothers, LLC
Nashville, TN 37219

Principal Display Panel

b+b
better by giving
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen
Pain Reliever/Fever Reducer
50 Caplets
(500 mg each)

PRINCIPAL DISPLAY PANELb+bbetter by givingEXTRA STRENGTHPAIN RELIEVERacetaminophenPain Reliever/Fever Reducer50 Caplets(500 mg each) - acetaminophen caplets 01