Medique Pain Off

Manufacturer
Sportpharm LLC
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:04

Label at a glance#

ProductMedique Pain Off
Active ingredientCAFFEINE, ACETAMINOPHEN, ASPIRIN
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 250 mg.

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to

■ headache ■ muscular aches ■ arthritis pain ■ a cold
■ toothache ■ premenstrual and menstrual cramps

WARNINGS SECTION

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 (NSAIDs) 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)

■ take more or for a longer time than directed

■ have 3 or more alcoholic drinks every day while using this product

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

OTC - DO NOT USE SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
drug contains acetaminophen, ask a doctor or pharmacist.

■ if you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

■ stomach bleeding warning applies to you

■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

■ you are taking a diuretic

■ you have a history of stomach problems such as heartburn

■ you have asthma

■ you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for gout, diabetes, or arthritis

■ taking any other drug, or under a doctor’s care for any serious condition

OTC - STOP USE SECTION

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

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ ringing in the ears or loss of hearing occurs

■ painful area is red or swollen

■ any new symptoms appear

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 specifically 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.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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not use more than directed

■ drink a full glass of water with each dose

Adults and children: (12 years and over)Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

Children under 12 years:Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ read all product information before using. Keep box for important information.

■ store at room temperature 68º-77ºF (20º-25ºC)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any opened or torn packets

■ each caplet contains: Magnesium 0.58 mg

INACTIVE INGREDIENT SECTION

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

OTC - QUESTIONS SECTION

Questions or comments?1-800-634-7680

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN2
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD2
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY2

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
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-173-01Medique Pain Off2 in 1 PACKETTABLET, FILM COATED22
85766-173-01Medique Pain Off50 in 1 BOXTABLET, FILM COATED502
85766-173-02Medique Pain Off100 in 1 BOXTABLET, FILM COATED1002
85766-173-02Medique Pain Off2 in 1 PACKETTABLET, FILM COATED22
85766-173-05Medique Pain Off250 in 1 BOXTABLET, FILM COATED2502
85766-173-05Medique Pain Off2 in 1 PACKETTABLET, FILM COATED22

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85766-17385766-173-05, 85766-173-01, 85766-173-02
47682-238

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-26monthly-update2026-06-03 17:58:26

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
ndc (package): 85766-173-05
ndc (package): 85766-173-01
ndc (package): 85766-173-02
ndc (product): 85766-173
ndc11 (package): 85766017305
ndc11 (package): 85766017301
ndc11 (package): 85766017302
spl id: 4c2c135f-ccc5-670c-e063-6394a90a8f4b
spl set id: 2b35acdc-ff88-46e6-a108-5240aac1d53f
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINEUnifirst First Aid Corporationc2d7af6b-f477-2462-e053-2995a90aff0f2025-09-08WarningsExact identifier
ndc (product): 47682-238

Reported adverse events (FAERS/openFDA)#

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