FDA Label for Pain Relief Extra Strength

Other

Drug Facts

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.

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Liver Warning

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

• more than 8 caplet in 24 hours
• 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 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

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/Pharmacist

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

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 use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

crosscarmellose sodium, lactose monohydrate, magnesium stearate, polethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide

Questions?

call 1-888-577-8033

Principal Display Panel - 200 Caplet Bottle Label

NDC 36800-150-20

Compare to the active ingredient
in Tylenol^® Extra Strength

EXTRA STRENGTH

Pain
Relief

ACETAMINOPHEN 500 mg
PAIN RELIEVER
FEVER REDUCER

200
CAPLETS

PRINCIPAL DISPLAY PANEL - 200 Caplet Bottle Label - topcare 01