Pain reliefextra strength tablet, coated

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
    • toothache
    • muscular aches
    • 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

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.

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 section

Ask a doctor before use if you haveliver disease.

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking 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 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 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.

Directions

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 20-25C (68-77F)
  • retain carton for complete product information

Inactive ingredients

hypromellose, mineral oil, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Ingredients and appearance - Product information

Pain reliefextra strength tablet, coated- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49738-780
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Hypromelloses ( UNII: 3NXW29V3WO)
Mineral oil ( UNII: T5L8T28FGP)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Povidone ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Sodium starch glycolate type a corn ( UNII: AG9B65PV6B)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color white Score 1
Shape OVAL Size 17 mm
Imprint Code M2A4;57344

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - SMART SENSE (KMART)( 008965873)

Principal display panel

Smart Sense™

Twin Pack

2 Bottles Inside

(2x100)

Compare to Tylenol® Extra Strength Caplets*

Extra Strength

Pain Relief

Acetaminophen

Pain Reliever / Fever Reducer

200 Caplets

500 mg