Acetaminophen 250mg Aspirin 250mg Caffeine 65mg

Manufacturer
WALGREENS CO.
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:50:46

Label at a glance#

ProductAcetaminophen 250mg Aspirin 250mg Caffeine 65mg
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each geltab)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes

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 • 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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

STORAGE AND HANDLING SECTION

• 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

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredients in Excedrin® Extra Strength††

Extra Strength

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED
walgreens.com 1-800-925-4733
©2021 Walgreen Co.

PRODUCT OF UNITED ARAB EMIRATES

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN5
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD5
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY5

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
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1320-12Acetaminophen 250mg Aspirin 250mg Caffeine 65mg120 in 1 BOTTLETABLET1205
0363-1320-23Acetaminophen 250mg Aspirin 250mg Caffeine 65mg20 in 1 BOTTLETABLET205
0363-1320-80Acetaminophen 250mg Aspirin 250mg Caffeine 65mg80 in 1 BOTTLETABLET805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1320ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG TABLET [WALGREENS CO.]5Current NDC, Legacy NDC, 3 package rows20250106_98bb28ed-d146-ca3d-e053-2a95a90a9eaf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1320-12EA - Each0363-13207b0882a8-9cf1-4088-b3fe-0d8f01da400012022-06-06
0363-1320-23EA - Each0363-132033b97d1a-4c50-4115-8277-b14f7d1fbe8812022-06-06
0363-1320-80EA - Each0363-1320bc5456cf-305d-490d-8c95-7f0ca9794f9612022-06-06

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-13200363-1320-12, 0363-1320-80, 0363-1320-23

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
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGWALGREENS CO.98bb28ed-d146-ca3d-e053-2a95a90a9eaf2024-12-26WarningsExact identifier
ndc (package): 0363-1320-23
ndc (package): 0363-1320-12
ndc (package): 0363-1320-80
ndc (product): 0363-1320
ndc11 (package): 00363132080
ndc11 (package): 00363132012
ndc11 (package): 00363132023
spl id: cbd064bd-32f1-4561-9b74-e0058a27d59a
spl set id: 98bb28ed-d146-ca3d-e053-2a95a90a9eaf

Reported adverse events (FAERS/openFDA)#

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