EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE- acetaminophen, aspirin (nsaid), and caffeine 
Haleon US Holdings LLC

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Drug Facts

Excedrin Tension Headache

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever aid

Uses

Warnings

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

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

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

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

  • if you are allergic to acetaminophen
  • 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 occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

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.

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

Other information

Inactive ingredients

benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-468-7746

Excedrin Extra Strength

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

Warnings

Reye’s syndrome:Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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

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

Allergy alert:Aspirin may cause a severe allergic reaction which may include:

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

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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 heart beat.

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are taking

  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or last for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms occur

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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

Other information

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Principal Display Panel (Excedrin Tension Headache)

NDC 0067-8139-01

EXCEDRIN ®

TENSION HEADACHE

Acetaminophen and Caffeine

Pain Reliever / Pain Reliever Aid

Aspirin Free

24CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare,

Warren, NJ 07059

©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies

Visit us at www.excedrin.com

46177299

46177299_Excedrin Tension HA_24 caps.JPG

Principal Display Panel (Excedrin Extra Strength)

NDC 0067-2000-91

EXCEDRIN ®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever / Pain Reliever Aid

100 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

©2015 GSK group of companies or its licensor. All rights reserved.

Visit us at www.excedrin.com

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.

46172044

46172044_Excedrin Extra Strength Caplets_100 ct
EXCEDRIN EXTRA STRENGTH AND EXCEDRIN TENSION HEADACHE 
acetaminophen, aspirin (nsaid), and caffeine kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8151
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8151-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product09/30/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 24 
Part 21 BOTTLE 100 
Part 1 of 2
EXCEDRIN   TENSION HEADACHE
acetaminophen, caffeine tablet, film coated
Product Information
Item Code (Source)NDC:0067-8139
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (Caplet) Size17mm
FlavorImprint Code ETH
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8139-011 in 1 CARTON
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/15/2016
Part 2 of 2
EXCEDRIN   EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Item Code (Source)NDC:0067-2000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeCAPSULE (Capsule-Shaped Tablet) Size18mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2000-911 in 1 CARTON
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/27/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/30/2018
Labeler - Haleon US Holdings LLC (079944263)

Revised: 2/2026
Document Id: 4b80ea7d-b5ef-e06c-e063-6294a90aafac
Set id: 2c8df1c7-7864-48df-939c-d9ae22e0f52c
Version: 5
Effective Time: 20260223
 
Haleon US Holdings LLC