MEDIQUE BACK PAIN RELIEF- magnesium salicylate tetrahydrate tablet, film coated 
Unifirst First Aid Corporation

----------

Medique Back Pain Relief

Drug Facts

Active ingredient (in each caplet)

Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg

(equivalent to 467.2 mg of anhydrous magnesium salicylate)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

For the temporary releif of minor backache pain

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

Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.

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

Ask a doctor or pharmacist before use if you are taking a prescription drug for

■ gout

■ diabetes

■ arthritis

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.

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.

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.

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 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 ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

Questions or comments? 1-800-634-7680

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

Medique Back

MEDIQUE BACK PAIN RELIEF 
magnesium salicylate tetrahydrate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-074
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE580 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Caplet) Size17mm
FlavorImprint Code 44;338
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-074-8040 in 1 BOX09/26/2022
1NDC:47682-074-992 in 1 PACKET; Type 0: Not a Combination Product
2NDC:47682-074-3675 in 1 BOX12/12/2022
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/26/2022
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 1/2024
Document Id: 0f1711c4-cd78-98f5-e063-6294a90ac9a6
Set id: e5563a0a-776a-83d4-e053-2a95a90a9500
Version: 3
Effective Time: 20240116
 
Unifirst First Aid Corporation