Your browser does not support JavaScript! EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [CARDINAL HEALTH]
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RxNorm Names

EXTRA STRENGTH PAIN RELIEVER (acetaminophen) tablet
[CARDINAL HEALTH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:

    • headache

    • the common cold

    • backache

    • minor pain of arthritis

    • toothache

    • muscular aches

    • premenstrual and menstrual cramps

  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

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 or 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 damage. In case of overdose, get medical help or contact a Poison Control Center (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

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

  • adults and children 12 years and over

    • take 2 tablets every 4 to 6 hours while symptoms last

    • do not take more than 8 tablets 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC 37205-659-78

LEADER®

Compare to Extra Strength Tylenol® active ingredient†

EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin

100 TABLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844   ORG021314812

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 1059773
www.myleader.com
1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Leader 44-148

Leader 44-148

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-659
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID 
STARCH, CORN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code 44;148
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-659-721 in 1 CARTON
160 in 1 BOTTLE
2NDC:37205-659-781 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/21/1993
Labeler - CARDINAL HEALTH (097537435)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37205-659)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37205-659)

Revised: 3/2013
 
CARDINAL HEALTH

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