FDA.reportPublic FDA data

Maximum Strength Backache Relief

Manufacturer
JHK DBA American Safety & First Aid | LNK International, INC
Effective date
2024-10-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:09

Label at a glance#

ProductMaximum Strength Backache Relief
Active ingredientMAGNESIUM SALICYLATE
Label structure10 sections

Dosage and administration

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.

Storage and handling

Each caplet contains: magnesium 40mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) tamper evident sealed packets do not use if packet is opened or torn

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Caplet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium salicylate tetrahydrate 580 mg (NSAID)1 (equivalent to 467.2 mg of anhydrous magnesium salicylate)

1 Nonsteroidal Anti-Inflammatory Drug

Purpose

OTC - PURPOSE SECTION

pain reliever/fever reducer

Use

INDICATIONS & USAGE SECTION

for the temporary relief of minor backache pain

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Magnesium salicylate may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to salicylates (including aspirin) or to any other pain reliever/fever reducer
  • for more than 10 days for pain unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask doctor before use if:

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • 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
    • 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 breastfeeding, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Each caplet contains: magnesium 40mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • tamper evident sealed packets
  • do not use if packet is opened or torn

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 580 mg Caplet Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

This product is not manufactured or distributed by
Dr Reddy's Laboratories, Inc
Owner of the registered trademark Doan's®.

Maximum Strength
Backache Relief

Product #1272

Pain Reliever/Fever Reducer

Active ingredient:
Magnesium Salicylate

  • Temporary relief from pain, fever, and inflammation
  • Soothes muscle aches and minor arthritis pain

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2021 standards. They are sealed in
tamper-evident packets for safety and convenience.

80 Caplets • 2 Caplets Per Packet

Principal Display Panel - 580 mg Caplet Packet Carton
Principal Display Panel - 580 mg Caplet Packet Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1272-1Maximum Strength Backache Relief2 in 1 PACKETCAPSULE, COATED22
73598-1272-1Maximum Strength Backache Relief40 in 1 CARTONCAPSULE, COATED402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1272MAXIMUM STRENGTH BACKACHE RELIEF (MAGNESIUM SALICYLATE) CAPSULE, COATED [JHK DBA AMERICAN SAFETY & FIRST AID]2Current NDC, 2 package rows20241009_f8cbcd4e-cfad-4592-8774-52e681494c45.zip

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
73598-127273598-1272-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM SALICYLATE41728CY7UXACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

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
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
ndc (package): 73598-1272-1
ndc (product): 73598-1272
ndc11 (package): 73598127201
spl id: f2839255-a361-4e8d-a1b4-c88ce9f1b794
spl set id: f8cbcd4e-cfad-4592-8774-52e681494c45

Reported adverse events (FAERS/openFDA)#

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