BACKPRIN
- Manufacturer
- HART Health
- Effective date
- 2024-12-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:40:25
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
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
OTC - PURPOSE SECTION
Purpose
Pain reliever
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves minor back pain
WARNINGS SECTION
Warnings
Reye's syndrome:
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with salicylates.
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
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 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 take any drug for diabetes, gout or arthritis
OTC - STOP USE SECTION
Stop use and ask a doctor if
■ an allergic reaction occurs, seek medical help right away
■ fever worsens or lasts more than 3 days
■ pain worsens or lasts more than 10 days
■ you experience any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ 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 right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions
Do not take more than directed.
Adults and children 12 years of age and over:
■ take 2 caplets with a full glass of water every 6 hours while symptoms persist
■ do not take more than 8 caplets in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor
OTHER SAFETY INFORMATION
Other information
■ caplets enclosed in a sealed packet
■ do not use if packet is torn, cut or open
■ store at 59° to 86°F (15°-30°C)
■ avoid excessive heat and humidity
INACTIVE INGREDIENT SECTION
Inactive ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50332-0140-4 | 2026-01-29 | C162847 | 48780-1 | 49896155-b386-586f-e063-e6dba90add90 | BACKPRIN |
| 50332-0140-7 | 2026-01-29 | C162847 | 48780-1 | 49896155-b386-586f-e063-e6dba90add90 | BACKPRIN |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0140 | BACKPRIN (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [HART HEALTH] | 2 | Unmatched | 20241206_c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c.zip |
Products#
Every source-derived product name is available through these pages.
- BACKPRIN
- Magnesium Salicylate Tetrahydrate
- 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 |
|---|---|
| 50332-0140 | 50332-0140-4, 50332-0140-7 |
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 |
|---|---|---|---|---|---|---|
| c626458a-510f-4dfd-ba65-5890dce22c0b | c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c | 2024-12-03 | Warnings | c626458a-510f-4dfd-ba65-5890dce22c0b c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
