Medique at Home Back Pain Relief

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:13:21

Label at a glance#

ProductMedique at Home Back Pain Relief
Active ingredientMAGNESIUM SALICYLATE
Label structure16 sections

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 relief 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 to 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. It is especially important not to use magnesium salicylate at 20 weeks or later in 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. 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 child resistant 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® @ Home

Back Pain Relief

Magnesium Salicylate Tetrahydrate

(NSAID) 580 mg

Pain Reliever

Pull to Open

Child-Resistant Packets

*not actual size

50 Packets

(2 Caplets Per Packet)

Medique HomeMedique Home

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198742magnesium salicylate 580 MG Oral TabletPSN5
198742magnesium salicylate 580 MG Oral TabletSCD5
198742magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-747-33Medique at Home Back Pain Relief50 in 1 BOXTABLET, FILM COATED505
47682-747-99Medique at Home Back Pain Relief2 in 1 PACKETTABLET, FILM COATED25

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-74747682-747-99, 47682-747-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Medique at Home Back Pain ReliefMAGNESIUM SALICYLATEUnifirst First Aid Corporatione56c4aef-fa0b-74db-e053-2a95a90a97452025-09-09WarningsExact identifier
ndc (package): 47682-747-99
ndc (package): 47682-747-33
ndc (product): 47682-747
ndc11 (package): 47682074799
ndc11 (package): 47682074733
spl id: 3e5d5cba-a762-29a3-e063-6394a90a7172
spl set id: e56c4aef-fa0b-74db-e053-2a95a90a9745

Reported adverse events (FAERS/openFDA)#

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