DrugCite

EXTRA STRENGTH ACETAMINOPHEN - acetaminophen tablet 
CARDINAL HEALTH

Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • toothache
    • the common cold
    • minor pain of arthritis
    • 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 8 caplets 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

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.

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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damamge. In case of overdose, get medical help or contact a Poison Control Center 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

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid

*may contain this ingredient

PRODUCT PACKAGING

NDC 37105-594-71

Compare to Extra Strength Tylenol® active ingredient

LEADER®

EXTRA STRENGTH

Pain Reliever

Acetaminophen • Contains No Aspirin

Pain Reliever/Fever Reducer

Caplets

50 CAPLETS - 500 mg EACH

Actual Size

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.

50844    ORG070917515

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4527503

www.myleader.com

1-800-200-6313

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

TAMPER EVIDENT: DO NT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader 44-175

Leader 44-175


EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 37205-594
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
STEARIC ACID  
CASTOR OIL  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 44;175
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 37205-594-71 1 BOTTLE In 1 CARTON contains a BOTTLE
1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (37205-594-71)
2 37205-594-78 1 BOTTLE In 1 CARTON contains a BOTTLE
2 100 TABLET In 1 BOTTLE This package is contained within the CARTON (37205-594-78)
3 37205-594-90 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/2023

Labeler - CARDINAL HEALTH (097537435)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Revised: 08/2012CARDINAL HEALTH