EXCEDRIN EXTRA STRENGTH CAPLETS- acetaminophen, aspirin (nsaid), and caffeine tablet, film coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

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

temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
toothache
premenstrual & menstrual cramps

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 a 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 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

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over: take 2 caplets  every 6 hours; not more than 8 caplets in 24 hours
children under 12 years: ask a doctor

Other information 

store at 20°- 25°C (68°- 77°F)
close cap tightly after use
read all product information before using. Keep this box for important information

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Principal Display Panel

NDC 0067-8104-50

EXCEDRIN®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Relieve/Pain Reliever Aid

50 CAPLETS

DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS BROKEN OR MISSING

KEEP BOX FOR REFERENCE

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

©2014

Visit us at www.excedrin.com

12043

Excedrin Extra Strength 50 count carton
EXCEDRIN  EXTRA STRENGTH CAPLETS
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8104
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeCAPSULE (Capsule-Shaped Tablet) Size18mm
FlavorImprint Code Ex
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8104-331 in 1 CARTON01/16/201307/09/2015
1300 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-8104-921 in 1 CARTON01/16/201311/04/2015
2200 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-8104-911 in 1 CARTON01/16/201307/13/2015
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-8104-241 in 1 CARTON01/16/201307/24/2015
424 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-8104-301 in 1 CARTON01/16/201305/24/2016
530 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-8104-831 in 1 CARTON01/16/201303/03/2016
6125 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0067-8104-501 in 1 CARTON01/16/201303/16/2018
750 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/16/201303/16/2018
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2019
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC