EXCEDRIN  EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin (nsaid), and caffeine tablet, film coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (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 loss of hearing occurs
  • 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
  • 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 3 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?

1-800-452-0051

Principal Display Panel

NDC 0067-2001-05

EXCEDRIN

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

100CAPLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2018 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

62000000032208

62000000032208_Excedrin ES Caplet_100 CT.JPG
EXCEDRIN   EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2001
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
Colorwhite (White) Scoreno score
ShapeCAPSULE (Capsule-Shaped Tablet) Size16mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2001-051 in 1 CARTON03/15/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-2001-081 in 1 CARTON03/15/2019
2300 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-2001-021 in 1 CARTON09/30/2020
324 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-2001-031 in 1 CARTON09/30/2020
430 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-2001-041 in 1 CARTON09/30/2020
550 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-2001-061 in 1 CARTON09/30/2020
6125 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0067-2001-071 in 1 CARTON09/30/2020
7200 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0067-2001-091 in 1 CARTON09/30/2020
8250 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0067-2001-012 in 1 POUCH; Type 0: Not a Combination Product01/31/2021
10NDC:0067-2001-141 in 1 BLISTER PACK01/31/2021
108 in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/15/2019
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 155eb367-99df-1f50-e063-6294a90a21d6
Set id: 1b5ff867-5442-4cf8-bd1e-530093cc88f8
Version: 10
Effective Time: 20240405
 
Haleon US Holdings LLC