EXCEDRIN EXTRA STRENGTH- acetaminophen, aspirin (nsaid), and caffeine tablet, film coated 
Select Corporation

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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Excedrin® Extra Strength

Drug Facts

Active ingredients (in each caplet)Purposes
*
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID*)Pain reliever
Caffeine 65 mgPain 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:

  • skin reddening
  • blisters
  • rash

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

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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 care 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

adults and children 12 years of age and overtake 2 caplets every 6 hours; not more than 8 caplets in 24 hours
under 12 yearsask a doctor

Other information

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcelluose, 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

Repackaged and Distributed by:
Select Corporation
Carrollton, TX 75007

Packaged and distributed by Select Corporation with the permission of
GSK Consumer Healthcare, Warren, NJ 07059

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Packet

EXCEDRIN®

EXTRA
STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

1 Packet of 2 Caplets

PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Packet
EXCEDRIN EXTRA STRENGTH 
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-868(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 (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:52904-868-041 in 1 BLISTER PACK01/23/2016
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-868-052 in 1 BLISTER PACK01/23/2016
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:52904-868-2525 in 1 CARTON01/23/2016
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:52904-868-5050 in 1 CARTON01/23/2016
42 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/23/2016
Labeler - Select Corporation (053805599)

Revised: 3/2022
Document Id: 055e2c6d-5d40-4f69-a5f7-9f96df4894d2
Set id: 60af6b21-9dc2-461e-a9bd-28d8e75cecb5
Version: 1
Effective Time: 20220324
 
Select Corporation