EXCEDRIN MIGRAINE (acetaminophen, aspirin- nsaid and caffeine tablet, film coated

EXCEDRIN by

Drug Labeling and Warnings

EXCEDRIN by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EXCEDRIN  MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-2039
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 (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
Color	WHITE (White)	Score	no score
Shape	CAPSULE (Capsule shaped tablet)	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-2039-02	2 in 1 POUCH; Type 0: Not a Combination Product	02/15/2010
2	NDC: 0067-2039-08	1 in 1 CARTON	02/15/2010	12/31/2014
2		8 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0067-2039-09	1 in 1 CARTON	02/15/2010	07/31/2017
3		10 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0067-2039-24	1 in 1 CARTON	02/15/2010
4		24 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0067-2039-30	1 in 1 CARTON	02/15/2010
5		30 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0067-2039-50	1 in 1 CARTON	02/15/2010
6		50 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0067-2039-94	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2010	12/31/2012
8	NDC: 0067-2039-91	1 in 1 CARTON	02/15/2010
8		100 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 0067-2039-83	1 in 1 CARTON	02/15/2010
9		125 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 0067-2039-84	125 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2010	07/31/2014
11	NDC: 0067-2039-86	1 in 1 CARTON	02/15/2010	12/31/2014
11		125 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 0067-2039-92	1 in 1 CARTON	02/15/2010
12		200 in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 0067-2039-77	1 in 1 CARTON	02/15/2010
13		250 in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 0067-2039-07	250 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2010	12/31/2012
15	NDC: 0067-2039-33	1 in 1 CARTON	02/15/2010
15		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
NDA	NDA020802	02/15/2010

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)