FDA.reportPublic FDA data

Doan's

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2026-04-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:55:01

Label at a glance#

ProductDoans Maximum Strength
Active ingredientMagnesium salicylate
Label structure12 sections

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: 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 45 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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

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 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 alcoholic 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.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have asthma
  • 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 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • vomit blood
    • feel faint
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over: 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 45 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-790-6417

PRINCIPAL DISPLAY PANEL - 24 Caplet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55741-600-34

MAXIMUM STRENGTH

DOAN'S®
MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)
PAIN RELIEVER


BACK PAIN RELIEF

24 CAPLETS

CartonCarton

PRINCIPAL DISPLAY PANEL - 30 Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55741-600-30

MAXIMUM STRENGTH

DOAN'S

MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg

PAIN RELIEVER (NSAID)

BACK PAIN RELIEF

30 CAPLETS

CartonCarton

30ct Container Label:

Bottle label
Bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
830388Doan's Extra Strength 580 MG Oral TabletPSN3
198742magnesium salicylate 580 MG Oral TabletPSN3
830388magnesium salicylate 580 MG Oral Tablet [Doans]SBD3
198742magnesium salicylate 580 MG Oral TabletSCD3
830388Doan's (magnesium salicylate tetrahydrate 580 MG (equivalent to 467.2 anhydrous magnesium salicylate)) Oral TabletSY3
830388Doan's 580 MG Oral TabletSY3
830388Doan's Extra Strength 580 MG Oral TabletSY3
198742magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-600-01Doans Maximum Strength1 in 1 CARTONTABLET13
55741-600-01Doans Maximum Strength100 in 1 BOTTLETABLET1003
55741-600-30Doans Maximum Strength30 in 1 BOTTLETABLET303
55741-600-30Doans Maximum Strength1 in 1 CARTONTABLET13
55741-600-34Doans Maximum Strength8 in 1 BLISTER PACKTABLET83
55741-600-34Doans Maximum Strength3 in 1 CARTONTABLET33

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
55741-60055741-600-34, 55741-600-01, 55741-600-30

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
hypromelloses3NXW29V3WOIACT
magnesium stearate70097M6I30IACT
cellulose, microcrystallineOP1R32D61UIACT
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
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
ndc (package): 55741-600-30
ndc (package): 55741-600-34
ndc (package): 55741-600-01
ndc (product): 55741-600
ndc11 (package): 55741060030
ndc11 (package): 55741060001
ndc11 (package): 55741060034
spl id: ce3b4271-d310-414e-d7c1-dea98afe2670
spl set id: c906df41-bb45-03ea-b1a8-2b9816d55c97

Reported adverse events (FAERS/openFDA)#

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