Back Pain Relief

Manufacturer
Wildman Business Group | LNK International, Inc. | Medique Products | Prestige Packaging
Effective date
2024-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:32

Label at a glance#

ProductBack Pain Relief Extra Strength Doans
Active ingredientMagnesium Salicylate
Label structure9 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

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

PURPOSE

OTC - PURPOSE SECTION

Purpose

Pain reliever

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses

For the temporary relief of minor backache pain

WARNINGS

WARNINGS SECTION

Warnings

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 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

OTC - DO NOT USE SECTION

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

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

OTC - ASK DOCTOR/PHARMACIST SECTION

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

  • gout
  • diabetes
  • arthritis

STOP USE

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
  • 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.

PREGNANCY OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • drink a full glass of water with each dose

Adults and children: (12 years and over)

SPL UNCLASSIFIED SECTION

Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours.

Children under 12 years:

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

QUESTIONS

OTC - QUESTIONS SECTION

Questions or comments? (888) 602-0288

Principal Display Panel – 50 Caplet Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2550

BACK PAIN RELIEF

Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

Pain Reliever / Anti-Inflammatory

Pull to Open

50 Caplets

2 Per Packet

The Provision

First Aid

Line™

BY WILDMAN

Principal Display Panel – 50 Caplet Box Label
Principal Display Panel – 50 Caplet Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
830388Doan's Extra Strength 580 MG Oral TabletPSN1
198742magnesium salicylate 580 MG Oral TabletPSN1
830388magnesium salicylate 580 MG Oral Tablet [Doans]SBD1
198742magnesium salicylate 580 MG Oral TabletSCD1
830388Doan's (magnesium salicylate tetrahydrate 580 MG (equivalent to 467.2 anhydrous magnesium salicylate)) Oral TabletSY1
830388Doan's 580 MG Oral TabletSY1
830388Doan's Extra Strength 580 MG Oral TabletSY1
198742magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130858704004202GTIN-13: 0858704004202
EAN-13: 0858704004202
GTIN-12: 858704004202
UPC-A: 858704004202
GTIN storage (14 digits): 00858704004202
bac0g-0000-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84269-2550-2Back Pain Relief Extra Strength Doans2 in 1 PACKETTABLET, FILM COATED21
84269-2550-2Back Pain Relief Extra Strength Doans50 in 1 BOXTABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84269-2550BACK PAIN RELIEF EXTRA STRENGTH DOANS (MAGNESIUM SALICYLATE) TABLET, FILM COATED [WILDMAN BUSINESS GROUP]1Current NDC, 2 package rows20240701_2e17664f-a83f-48d1-8b2b-37f41eea65b6.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
84269-255084269-2550-2

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
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
ndc (package): 84269-2550-2
ndc (product): 84269-2550
ndc11 (package): 84269255002
spl id: f69e4213-b807-4e45-9bc8-94c8f3449aae
spl set id: 2e17664f-a83f-48d1-8b2b-37f41eea65b6

Reported adverse events (FAERS/openFDA)#

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