EXCEDRIN EXTRA STRENGTH HEADACHE (acetaminophen, aspirin- nsaid, caffeine tablet, film coated

Excedrin by

Drug Labeling and Warnings

Excedrin by is a Otc medication manufactured, distributed, or labeled by Select Consumer Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 and 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

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

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 occur

These could be signs of a serious condition.

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

drink a full glass of water with each dose

adults and children 12 years of age 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 (24 ct)

Inactive ingredients (100 ct)

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-468-7746

Package/Label Principal Display Panel (24 ct.)

EXCEDRIN

EXTRA STRENTH HEADACHE

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

ACTUAL SIZE

24 CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies. 62000000201911

Package/Label Principal Display Panel (100 ct.)

EXCEDRIN

EXTRA STRENGTH HEADACHE

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

ACTUAL SIZE

100
CAPLETS

TAMPER-EVIDENT BOTTLE

DO NOT IF USE PRINTED INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed
to the Haleon group of companies.

INGREDIENTS AND APPEARANCE

EXCEDRIN  EXTRA STRENGTH HEADACHE
acetaminophen, aspirin (nsaid), caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85237-1868(NDC:0067-2003)
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	ES
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85237-1868-1	1 in 1 BLISTER PACK	01/01/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 85237-1868-2	2 in 1 BLISTER PACK	01/01/2024
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 85237-1868-3	25 in 1 BOX, UNIT-DOSE	01/01/2024
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 85237-1868-4	50 in 1 BOX, UNIT-DOSE	01/01/2024
4		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/01/2024

Labeler - Select Consumer Group (119185084)

Establishment
Name	Address	ID/FEI	Business Operations
Select Consumer Group		119185084	repack(85237-1868)