Medique Back Pain Relief
- Manufacturer
- Unifirst First Aid Corporation
- Effective date
- 2025-09-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:06
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg
(equivalent to 467.2 mg of anhydrous magnesium salicylate)
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
INDICATIONS & USAGE SECTION
Uses
For the temporary releif of minor backache pain
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:
Magnesium salicylate may cause a severe allergic reaction, which may include:
■ hives
■ facial swelling
■ asthma (wheezing)
■ shock
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 alcohol drinks every day while using this product
■ take more or for a longer time than directed
OTC - DO NOT USE SECTION
Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
■ 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 have asthma
■ you are taking a diuretic
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for
■ gout
■ diabetes
■ arthritis
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
■ if ringing in the ears or loss of hearing occurs
■ new symptoms occur
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
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. I t is especially important not to use magnesium salicylate 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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
■ drink a full glass of water with each dose
Adults and children: (12 years and over)
Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours.
Children under 12 years:
Do not use unless directed by a doctor
OTHER SAFETY INFORMATION
Other information
■ each caplet contains: magnesium 40 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ tamper evident sealed packets
■ do not use any opened or torn packets
INACTIVE INGREDIENT SECTION
Inactive ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
OTC - QUESTIONS SECTION
Questions or comments? 1-800-634-7680
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medique®
Back Pain Relief
Pain Reliever/ Anti-Inflammatory
Pull to Open
Magnesium Salicylate Tetrahydrate (NSAID) 580 mg
80 Caplets (40 x 2)
Tamper Evident Unit Dose Packets
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-074-36 | Medique Back Pain Relief | 75 in 1 BOX | TABLET, FILM COATED | 75 | 5 | |
| 47682-074-36 | Medique Back Pain Relief | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 5 | |
| 47682-074-80 | Medique Back Pain Relief | 40 in 1 BOX | TABLET, FILM COATED | 40 | 5 | |
| 47682-074-99 | Medique Back Pain Relief | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 5 |
Products#
Every source-derived product name is available through these pages.
- Medique Back Pain Relief
- Magnesium Salicylate Tetrahydrate
- MAGNESIUM SALICYLATE
- SALICYLIC ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STEARIC ACID
- CELLULOSE, MICROCRYSTALLINE
- MAGNESIUM STEARATE
- POLYDEXTROSE
- TITANIUM DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-074 | 47682-074-99, 47682-074-80, 47682-074-36 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM SALICYLATE | 41728CY7UX | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TRIACETIN | XHX3C3X673 | 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 Back Pain Relief | MAGNESIUM SALICYLATE TETRAHYDRATE | Unifirst First Aid Corporation | e5563a0a-776a-83d4-e053-2a95a90a9500 | 2025-09-08 | Warnings | 47682-074-99 47682-074-80 47682-074-36 47682-074 47682007480 47682007499 47682007436 3e4cc387-246f-c235-e063-6294a90aaa86 e5563a0a-776a-83d4-e053-2a95a90a9500 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
