Medique Pain Off
- Manufacturer
- Unifirst First Aid Corporation
- Effective date
- 2025-09-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:02
Label at a glance#
Contacts and useful links#
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique®
Pain-Off®
Extra Strength Pain Relief
Alivio al dolor extra fuerte
Pain Reliever/Fever Reducer • Acetaminophen 250 mg Aspirin (NSAID) 250 mg
Alivia el Dolor/Reduce la Fiebre • Acetaminofeno 250 mg Aspirina (AINE) 250 mg
Pain Reliever Aid • Caffeine 65 mg
Ayunda al alivio del dolor • Cafina 65 mg
Pull to Open
Tire Para Abrir
200 Caplets (100 x 2)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Untarias
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-238-13 | Medique Pain Off | 250 in 1 BOX | TABLET, FILM COATED | 250 | 10 | |
| 47682-238-13 | Medique Pain Off | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 10 | |
| 47682-238-33 | Medique Pain Off | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 10 | |
| 47682-238-33 | Medique Pain Off | 50 in 1 BOX | TABLET, FILM COATED | 50 | 10 | |
| 47682-238-47 | Medique Pain Off | 100 in 1 BOX | TABLET, FILM COATED | 100 | 10 | |
| 47682-238-47 | Medique Pain Off | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 10 | |
| 47682-238-99 | Medique Pain Off | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 10 |
Products#
Every source-derived product name is available through these pages.
- Medique Pain Off
- Acetaminophen, Aspirin, Caffeine
- SILICON DIOXIDE
- TALC
- CAFFEINE
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- ACETAMINOPHEN
- ASPIRIN
- POVIDONE, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-238 | 47682-238-13, 47682-238-33, 47682-238-99, 47682-238-47 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Medique Pain Off | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Unifirst First Aid Corporation | c2d7af6b-f477-2462-e053-2995a90aff0f | 2025-09-08 | Warnings | 47682-238-33 47682-238-99 47682-238-47 47682-238-13 47682-238 47682023813 47682023833 47682023847 47682023899 3e4ce426-b2b3-feae-e063-6294a90a95c7 c2d7af6b-f477-2462-e053-2995a90aff0f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
