TENSION HEADACHE- acetaminophen, caffeine tablet, film coated 
Cardinal Health 110, LLC. DBA Leader

----------

Leader 44-428

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 65 mg

Purpose

Pain reliever
Pain reliever aid

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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

If a skin reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

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

  • any new symptoms appear
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal Display Panel

LEADER

NDC 70000-0159-1

Tension Headache
Acetaminophen,
500 mg
Caffeine, 65 mg
Pain reliever Pain Reliever Aid

Aspirin-Free

COMPARE TO
EXCEDRIN®
TENSION
HEADACHE

active ingredients*

100% Money
Back Guarantee

24 CAPLETS

Actual Size

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

*This product is not manufactured or distributed by
Haleon CH SARL, owner of the registered trademark
Excedrin® Tension Headache.

50844 REV0824C42808

©2025 Cardinal Health. All Rights Reserved. CARDINAL
HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
LEADER, and the LEADER LOGO are trademarks or registered
trademarks of Cardinal Health. All other marks are the
property of their respective owners.

CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979 

100% Money Back Guarantee
Return to place of purchase if not satisfied.

Leader 44-428

Leader 44-428

TENSION HEADACHE 
acetaminophen, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0159
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0159-11 in 1 CARTON01/17/2007
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0159-21 in 1 CARTON01/17/2007
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/17/2007
Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(70000-0159)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(70000-0159)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(70000-0159)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(70000-0159)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(70000-0159)

Revised: 1/2026
Document Id: 9c6c0237-6c88-4740-9f20-83ad3fad89ab
Set id: 96684e3f-a13e-49c3-b437-d2627e528a2d
Version: 14
Effective Time: 20260112
 
Cardinal Health 110, LLC. DBA Leader