FDA Label for Pain Reliever

Drug Facts

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Otc - Active Ingredient

Active ingredient (in each caplet)

Acetaminophen 500 mg

Otc - Purpose

Purpose

Pain reliever/fever reducer

Indications & Usage

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

Warnings

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:

• skin reddening
• blisters
• rash

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

Otc - Do Not Use

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

Otc - Stop Use

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.

Overdosage

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

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 Safety Information

Other information

store between 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredientscarnauba wax, FD&C red no. 40 al. lake, FD&C yellow no. 6 al. lake, guar gum, hypromellose, light mineral oil, maltodextrin, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Otc - Questions

Questions or comments? Call 1-877-290-4008