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#
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
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
Purpose
Pain reliever
INDICATIONS & USAGE
Uses
For the temporary relief of minor backache pain
WARNINGS
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
Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
ASK DOCTOR
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
STOP USE
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
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
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
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 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 ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
QUESTIONS
Questions or comments? (888) 602-0288
Principal Display Panel – 50 Caplet Box Label
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 830388 | Doan's Extra Strength 580 MG Oral Tablet | PSN | 1 |
| 198742 | magnesium salicylate 580 MG Oral Tablet | PSN | 1 |
| 830388 | magnesium salicylate 580 MG Oral Tablet [Doans] | SBD | 1 |
| 198742 | magnesium salicylate 580 MG Oral Tablet | SCD | 1 |
| 830388 | Doan's (magnesium salicylate tetrahydrate 580 MG (equivalent to 467.2 anhydrous magnesium salicylate)) Oral Tablet | SY | 1 |
| 830388 | Doan's 580 MG Oral Tablet | SY | 1 |
| 830388 | Doan's Extra Strength 580 MG Oral Tablet | SY | 1 |
| 198742 | magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral Tablet | SY | 1 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0858704004202 | GTIN-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 | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84269-2550-2 | Back Pain Relief Extra Strength Doans | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 1 | |
| 84269-2550-2 | Back Pain Relief Extra Strength Doans | 50 in 1 BOX | TABLET, FILM COATED | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 84269-2550 | BACK PAIN RELIEF EXTRA STRENGTH DOANS (MAGNESIUM SALICYLATE) TABLET, FILM COATED [WILDMAN BUSINESS GROUP] | 1 | Current NDC, 2 package rows | 20240701_2e17664f-a83f-48d1-8b2b-37f41eea65b6.zip |
Products#
Every source-derived product name is available through these pages.
- Back Pain Relief Extra Strength Doans
- Magnesium Salicylate
- Salicylic Acid
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STEARIC ACID
- CELLULOSE, MICROCRYSTALLINE
- MAGNESIUM STEARATE
- POLYDEXTROSE
- TITANIUM DIOXIDE
- HYPROMELLOSE, UNSPECIFIED
- TRIACETIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84269-2550 | 84269-2550-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Magnesium Salicylate | 41728CY7UX | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Back Pain Relief Extra Strength Doans | MAGNESIUM SALICYLATE | Wildman Business Group | 2e17664f-a83f-48d1-8b2b-37f41eea65b6 | 2024-07-01 | Warnings | 84269-2550-2 84269-2550 84269255002 f69e4213-b807-4e45-9bc8-94c8f3449aae 2e17664f-a83f-48d1-8b2b-37f41eea65b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
