EXCEDRIN EXTRA STRENGTH PAIN RELIEVER- 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 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

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

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 0067-2000-10

EXCEDRIN®

EXTRA STRENGTH

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

10 CAPLETS

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

©2015 GSK or its licensor.

Visit us at www.excedrin.com

46172146

46172146_Excedrin Extra Strength caplets_10 ct.JPG
EXCEDRIN  EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin (nsaid), and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2000
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE (White) Score no score
Shape CAPSULE (Capsule-Shaped Tablet) Size 18mm
Flavor Imprint Code E
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0067-2000-02 2 in 1 POUCH; Type 0: Not a Combination Product 09/27/2006
2 NDC:0067-2000-10 1 in 1 CARTON 09/27/2006
2 10 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:0067-2000-24 1 in 1 CARTON 09/27/2006
3 24 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:0067-2000-30 1 in 1 CARTON 09/27/2006
4 30 in 1 BOTTLE; Type 0: Not a Combination Product
5 NDC:0067-2000-50 1 in 1 CARTON 09/27/2006
5 50 in 1 BOTTLE; Type 0: Not a Combination Product
6 NDC:0067-2000-91 1 in 1 CARTON 09/27/2006
6 100 in 1 BOTTLE; Type 0: Not a Combination Product
7 NDC:0067-2000-94 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2006 12/31/2014
8 NDC:0067-2000-83 1 in 1 CARTON 09/27/2006
8 125 in 1 BOTTLE; Type 0: Not a Combination Product
9 NDC:0067-2000-20 1 in 1 CARTON 09/27/2006
9 200 in 1 BOTTLE; Type 0: Not a Combination Product
10 NDC:0067-2000-77 1 in 1 CARTON 09/27/2006
10 250 in 1 BOTTLE; Type 0: Not a Combination Product
11 NDC:0067-2000-07 250 in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2006 12/31/2014
12 NDC:0067-2000-33 1 in 1 CARTON 09/27/2006
12 300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 09/27/2006
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2018
Document Id: 6c598c58-a6c7-43f3-9a22-40625c63aa3b
Set id: a71074a6-cc19-4bb3-8c84-4e82a8906801
Version: 9
Effective Time: 20181112
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC