Dosage and administration
drink a full glass of water with each dose adults: 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
Doans
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Effective date
- 2016-06-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:51
Label at a glance#
ProductDoans Extra Strength
Active ingredientMagnesium salicylate
Label structure10 sections
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN each caplet contains: magnesium 50 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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Purpose
Pain reliever
Use
for the temporary relief 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 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
- 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
Stop use and ask a doctor if
- 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
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- redness or swelling is present
- 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
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 during the last 3 months of 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
- drink a full glass of water with each dose
- adults: 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
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- each caplet contains: magnesium 50 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
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
Questions or comments?
1-800-790-6417
PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Box
NDC 55741-224-24
EXTRA STRENGTH
DOAN'S®
MAGNESIUM SALICYLATE TETRAHYDRATE 580 mg each (NSAID)
PAIN RELIEVER
RELIEVES
BACKACHE
PAIN
24 CAPLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 830388 | Doan's Extra Strength 580 MG Oral Tablet | PSN | 3 |
| 198742 | magnesium salicylate 580 MG Oral Tablet | PSN | 3 |
| 830388 | magnesium salicylate 580 MG Oral Tablet [Doans] | SBD | 3 |
| 198742 | magnesium salicylate 580 MG Oral Tablet | SCD | 3 |
| 830388 | Doan's (magnesium salicylate tetrahydrate 580 MG (equivalent to 467.2 anhydrous magnesium salicylate)) Oral Tablet | SY | 3 |
| 830388 | Doan's 580 MG Oral Tablet | SY | 3 |
| 830388 | Doan's Extra Strength 580 MG Oral Tablet | SY | 3 |
| 198742 | magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral Tablet | SY | 3 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55741-224-24 | Doans Extra Strength | 24 in 1 BOTTLE | TABLET | 24 | 3 | |
| 55741-224-24 | Doans Extra Strength | 1 in 1 BOX | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55741-224-24 | EA - Each | 55741-224 | 8baa5894-ef60-4dbd-a15a-84aebe9ed230 | 1 | 2024-01-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Magnesium salicylate | ACTIVE INGREDIENT | 41728CY7UX | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Products#
Every source-derived product name is available through these pages.
- Doans Extra Strength
- Magnesium salicylate
- SALICYLIC ACID
- hypromelloses
- magnesium stearate
- cellulose, microcrystalline
- polydextrose
- POLYETHYLENE GLYCOL, UNSPECIFIED
- stearic acid
- titanium dioxide
- triacetin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55741-224 | 55741-224-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Magnesium salicylate | 41728CY7UX | ACTIB |
| hypromelloses | 3NXW29V3WO | IACT |
| magnesium stearate | 70097M6I30 | IACT |
| cellulose, microcrystalline | OP1R32D61U | IACT |
| polydextrose | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| stearic acid | 4ELV7Z65AP | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| triacetin | XHX3C3X673 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| triacetin | TRIACETIN | XHX3C3X673 | TABLET / ORAL | 208 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Doans Extra Strength | MAGNESIUM SALICYLATE | Dr. Reddy's Laboratories Inc. | d98ee9c8-40e2-4abb-b5c1-45e73e7dd23b | 2016-06-15 | Warnings | 55741-224-24 55741-224 55741022424 ae997d0c-8097-dc21-0cc8-7763170761cf d98ee9c8-40e2-4abb-b5c1-45e73e7dd23b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.