EXCEDRIN EXTRA STRENGTH- 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 ingredient (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
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:

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 tables 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 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 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
high blood pressure
you have asthma

Ask a doctor or pharmacist before use

any other drug containing an NSAID (prescription or nonprescription)
a blood thinning (anticoagulant) or steroid drug
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 os 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 appear

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

Overdose Warning

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 (see Overdose Warning)
drink a full glass of water with each dose
adults and children 12 years and over: take 2 tablets  every 6 hours; not more than 8 tables  in 24 hours
children under 12 years: ask a doctor

Other information 

store at controlled room temperature 200 -  250 C (680 -  770 F)
read all product information before using. Keep this box for important information

 

Inactive ingredients

benzoic acid, carnauba wax, FD&C blue #1, hydroxypropyl cellulose, 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 E.S. Tablets
EXCEDRIN  EXTRA STRENGTH
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2030
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DIMETHICONE 410 (UNII: TYU5GP6XGE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2030-061 in 1 CARTON09/27/200612/31/2014
16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0067-2030-081 in 1 CARTON09/27/200612/31/2014
28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0067-2030-241 in 1 CARTON09/27/200612/31/2014
324 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0067-2030-501 in 1 CARTON09/27/200612/31/2014
450 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:0067-2030-911 in 1 CARTON09/27/200612/31/2014
5100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:0067-2030-94100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/200612/31/2014
7NDC:0067-2030-831 in 1 CARTON09/27/200612/31/2014
7125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:0067-2030-921 in 1 CARTON09/27/200612/31/2014
8200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC:0067-2030-5150 in 1 BOX, UNIT-DOSE09/27/200612/31/2014
9NDC:0067-2030-022 in 1 PACKET; Type 0: Not a Combination Product
10NDC:0067-2030-07250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/200612/31/2014
11NDC:0067-2030-771 in 1 CARTON09/27/200612/31/2014
11250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
12NDC:0067-2030-331 in 1 CARTON09/27/200612/31/2014
12300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
13NDC:0067-2030-57300 in 1 BOTTLE; Type 0: Not a Combination Product09/27/200612/31/2014
14NDC:0067-2030-301 in 1 CARTON09/27/200612/31/2014
1430 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/27/200612/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 3/2017
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC