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

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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

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

treats migraine

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 2 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

Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.

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 doctor before use if

you have never had migraines diagnosed by a health professional
you have a headache that is different from your usual migraines
you have the worst headache of your life
you have fever and stiff neck
you have headaches beginning after or caused by head injury, exertion, coughing or bending
you experienced your first headache after the age of 50
you have daily headaches
you have a migraine so severe as to require bed rest
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
you have problems or serious side effects from taking pain relievers or fever reducers
you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are

taking a prescription drug for:
diabetes
gout
arthritis
under a doctor’s care for any serious condition
taking any other drug
taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

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
your migraine is not relieved or worsens after first dose
new or unexpected symptoms occur
ringing in the ears or loss of hearing occurs

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
adults: take 2 caplets with a glass of water
if symptoms persist or worsen, ask your doctor
do not take more than 2 caplets in 24 hours, unless directed by a doctor
under 18 years of age: ask a doctor

Other information

store at controlled room temperature 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?

1-800-468-7746

Principal Display Panel

NDC 0067-2039-24

See new warnings information

EXCEDRIN®

MIGRAINE

Acetaminophen, Aspirin (NSAID) and Caffeine

Pain Reliever/Pain Reliever Aid

24

CAPLETS*

*CAPSULE-SHAPED TABLETS

TAMPER-EVIDENT BOTTLE

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

©2017 GSK or its licensor.

Visit us at www.excedrin.com

62000000012933

62000000012933_Excedrin Migraine Caplets_24 ct.JPG
EXCEDRIN  MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2039
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2039-022 in 1 POUCH; Type 0: Not a Combination Product02/15/2010
2NDC:0067-2039-081 in 1 CARTON02/15/201012/31/2014
28 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0067-2039-091 in 1 CARTON02/15/201007/31/2017
310 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0067-2039-241 in 1 CARTON02/15/2010
424 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0067-2039-301 in 1 CARTON02/15/2010
530 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0067-2039-501 in 1 CARTON02/15/2010
650 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0067-2039-94100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201012/31/2012
8NDC:0067-2039-911 in 1 CARTON02/15/2010
8100 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0067-2039-831 in 1 CARTON02/15/2010
9125 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0067-2039-84125 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201007/31/2014
11NDC:0067-2039-861 in 1 CARTON02/15/201012/31/2014
11125 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0067-2039-921 in 1 CARTON02/15/2010
12200 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:0067-2039-771 in 1 CARTON02/15/2010
13250 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:0067-2039-07250 in 1 BOTTLE; Type 0: Not a Combination Product02/15/201012/31/2012
15NDC:0067-2039-331 in 1 CARTON02/15/2010
15300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080202/15/2010
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 10/2019
Document Id: 3f438261-cc26-4154-aa36-959354870fb3
Set id: 7ed841fb-a61c-4868-b4e5-4f2311a5e79c
Version: 11
Effective Time: 20191002
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC