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#

ProductBACKPRIN
Active ingredientMAGNESIUM SALICYLATE
Label structure14 sections

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

Backprin.jpgBackprin.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198742magnesium salicylate 580 MG Oral TabletPSN2
198742magnesium salicylate 580 MG Oral TabletSCD2
198742magnesium salicylate 580 MG (as magnesium salicylate anhydrous 467 MG) Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0140-42026-01-29C16284748780-149896155-b386-586f-e063-e6dba90add90BACKPRIN
50332-0140-72026-01-29C16284748780-149896155-b386-586f-e063-e6dba90add90BACKPRIN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0140BACKPRIN (MAGNESIUM SALICYLATE TETRAHYDRATE) TABLET, FILM COATED [HART HEALTH]2Unmatched20241206_c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-014050332-0140-4, 50332-0140-7

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
c626458a-510f-4dfd-ba65-5890dce22c0bc8d1cffc-9483-4462-9f92-c0c2fbfc2b7c2024-12-03WarningsExact identifier
spl id: c626458a-510f-4dfd-ba65-5890dce22c0b
spl set id: c8d1cffc-9483-4462-9f92-c0c2fbfc2b7c

Reported adverse events (FAERS/openFDA)#

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