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Extra Strength ACETAMINOPHEN 500 MG Caplet


SPL UNCLASSIFIED SECTION

Drug Facts


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
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

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

OTHER SAFETY INFORMATION

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

  • skin reddening
  • blisters
  • rash

OTC - DO NOT USE SECTION

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 ingredient 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/pharmacist before use if you are

  • taking the blood thinning drug warfarin

OTC - STOP USE SECTION

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
  • redness or swelling is present
  • new symptoms occur

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 Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or 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 at 20º - 25ºC (68º -77ºF)

Inactive ingredients

Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide


SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: Do not use if imprinted saftey seal under cap is broken or missing.


SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.


Distributed by:

GenCare Consumer Products LLC

40E Cotters Ln Suite A,

East Brunswick, NJ 08816


NDC 72090-008-30 (300 tablets in a bottle)