WALGREENS HEADACHE RELIEF EXTRA STRENGTH- acetaminophen 250mg, aspirin 250mg and caffeine 65mg tablet, coated

Drug Labeling and Warnings

Drug Details [pdf]

DRUG FACTS

DRUG FACTS

Active Ingredient (in each softgel)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

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 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 geltabs 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 occasional rapid heartbeat.

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

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 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.

Overdose warning: In case of overdose, get medical help or
contact a Poison Control Center right away. Prompt medical
attention is critical for adults as well as children even if you do
not notice any signs or symptoms.

Directions

■ do not use more than directed (see overdose warning)
■ drink a full glass of water with each dose
■ adults and children 12 years and over: take 2 geltabs every
6 hours; not more than 8 geltabs in 24 hours
■ children under 12 years: ask a doctor

Other information

■ store at room temperature between 20-25°C (68-77°F)
■ avoid excessive heat, cold and humidity

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl
cellulose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum
lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose
monohydrate, light mineral oil, microcrystalline cellulose, pregelatinized
potato starch, purified water, pvpk-30, sorbitol sorbitan solution,
stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

1-888-333-9792 Monday-Friday 8am-4pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS HEADACHE RELIEF EXTRA STRENGTH 
acetaminophen 250mg, aspirin 250mg and caffeine 65mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6693
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
POVIDONE K30 (UNII: U725QWY32X)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	green (Dark Green and White Opaque)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	43
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6693-20	1 in 1 CARTON	05/01/2026
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0363-6693-80	1 in 1 CARTON	05/01/2026
2		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 0363-6693-12	1 in 1 CARTON	05/01/2026
3		120 in 1 BOTTLE, PLASTIC; 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	05/01/2026

Labeler - Walgreens (008965063)