EXTRA STRENGTH PAIN RELIEVER- acetaminophen tablet 
CARDINAL HEALTH

Disclaimer: 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.

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Leader 44-148

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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:

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

Other information

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 37205-659-72

LEADER®

Compare to
Extra Strength
Tylenol®
active ingredient†

EXTRA STRENGTH
Pain Reliever

Acetaminophen • Contains No Aspirin
Pain Reliever/Fever Reducer

SATISFACTION
GUARANTEED

60 TABLETS - 500 mg EACH

Actual Size

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844   REV213A14811

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 4527495
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 NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CVS 44-148

CVS 44-148

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-659
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONES (UNII: FZ989GH94E)  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 12mm
Flavor Imprint Code 44;148
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-659-72 1 in 1 CARTON
1 60 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:37205-659-78 1 in 1 CARTON
2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/21/1993
Labeler - CARDINAL HEALTH (097537435)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(37205-659)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(37205-659)

Revised: 3/2015
Document Id: e562c0e9-2a6d-490b-a0d7-5ade5e2e684a
Set id: b4c66875-0eb4-4f76-9c0d-fc1701c9b9f2
Version: 12
Effective Time: 20150319
 
CARDINAL HEALTH