EXCEDRIN MIGRAINE RELIEF (acetaminophen, aspirin- nsaid, 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, Lianyungang Kangle Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 250mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Use

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 at 20 weeks or later in 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 no. 1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Principal Display Panel

EXCEDRIN

MIGRAINE RELIEF

Acetaminophen 250 mg, Aspirin 250 mg (NSAID)
and Caffeine 65 mg
Pain Reliever / Pain Reliever Aid

ACTUAL SIZE

24
CAPLETS*
*CAPSULE-SHAPED TABLETS

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000202358

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-2042
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
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	Score	no score
Shape	CAPSULE (Capsule-shaped tablet)	Size	16mm
Flavor		Imprint Code	E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-2042-01	1 in 1 CARTON	01/01/2024
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0067-2042-02	1 in 1 CARTON	01/01/2024
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0067-2042-03	1 in 1 CARTON	01/01/2024
3		50 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 0067-2042-04	1 in 1 CARTON	01/01/2024
4		100 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 0067-2042-05	1 in 1 CARTON	01/01/2024
5		125 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 0067-2042-06	1 in 1 CARTON	01/01/2024
6		200 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 0067-2042-07	1 in 1 CARTON	01/01/2024
7		250 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 0067-2042-08	300 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020802	01/01/2024

Labeler - Haleon US Holdings LLC (079944263)