FDA Label for Acetaminophen

Active Ingredient (In Each Tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

• the commom cold
• headache
• backache
• minor pain of arthritis
• toothache
• muscular aches
• menstrual cramps

Temporarily reduces fever

Warnings

Liver warning:

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

• more than 8 tablets 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 warning:Acetaminophen may cause severe skin reaction. 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

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.

Overdose Warning:

In the case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).

Directions

• do not take more than directed (see overdose warning).
  
• Adult and Children 12 years and over: take 2 tablets, every 4 to 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.
  

Inactive Ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8AM to 4PM

16 How Supplied/Storage And Handling

Acetaminophen tablets, 500mg, are available for oral administration as white, round, imprinted with PH044 .

Bottles of 24 (NDC 55289-880-24)

Bottles of 30 (NDC 55289-880-30)

Bottles of 100 (NDC 55289-880-01)

Storage Store at 20°C to 25°C (68°F to 77°F)