Walgreens Headache Relief Extra Strength GELTAB

Manufacturer
Walgreens
Effective date
2026-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:54

Label at a glance#

ProductWalgreens Headache Relief Extra Strength
Active ingredientCAFFEINE, ASPIRIN, ACETAMINOPHEN
Label structure16 sections

Indications and uses

Temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual and menstrual cramps

Dosage and administration

■ 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

Label contents#

Full prescribing information#

DRUG FACTS

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

■ headache ■ a cold ■ arthritis ■ muscular aches

■ toothache ■ premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonCartonCartonCartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN1
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD1
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-6693-12Walgreens Headache Relief Extra Strength1 in 1 CARTONTABLET, COATED11
0363-6693-12Walgreens Headache Relief Extra Strength120 in 1 BOTTLE, PLASTICTABLET, COATED1201
0363-6693-20Walgreens Headache Relief Extra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED201
0363-6693-20Walgreens Headache Relief Extra Strength1 in 1 CARTONTABLET, COATED11
0363-6693-80Walgreens Headache Relief Extra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED801
0363-6693-80Walgreens Headache Relief Extra Strength1 in 1 CARTONTABLET, COATED11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-66930363-6693-20, 0363-6693-80, 0363-6693-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
ndc (package): 0363-6693-80
ndc (package): 0363-6693-12
ndc (package): 0363-6693-20
ndc (product): 0363-6693
ndc11 (package): 00363669312
ndc11 (package): 00363669380
ndc11 (package): 00363669320
spl id: 52109b65-3bf2-de38-e063-6394a90a9727
spl set id: 52109b65-3bf1-de38-e063-6394a90a9727

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.