Backprin

Manufacturer
HART Health
Effective date
2020-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:24

Label at a glance#

ProductBackprin
Active ingredientACETAMINOPHEN, CAFFEINE, MAGNESIUM SALICYLATE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet):

Acetaminophen 250 mg

Caffeine 50 mg

Magnesium Salicylate (NSAID*) 290 mg (*nonsteroidal anti-inflammatory drug)

OTC - PURPOSE SECTION

Purpose:

Pain Reliever/Fever Reducer

Pain Reliever Aid

Pain Reliever/Fever Reducer

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: Acetaminophen and Magnesium Salicylate may cause severe allergic reaction which may include hives, skin reddening, blisters, rash, facial swelling, asthma (wheezing), or shock.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is highter if you:

  • take more or for a longer time than directed
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or non-prescription NSAID (aspirin, ibuprofen, naproxen, others)

OTC - DO NOT USE SECTION

Do not use:

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or non-prescription)

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn

Ask a doctor or pharmacist before use if you

  • take a blood thinning (anticoagulant) or steroid drug
  • take any drug for diabetes, gout or arthritis
  • do not know if other drugs you are taking contain acetaminophen
  • take any other drug containing an NSAID

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • an allergic reaction occurs, seek medical help right away
  • fever worsens or lasts for more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • pain worsens or lasts for more than 10 days
  • ringing in the ears or a loss of hearing occurs
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloods or black stools, or stomach pain that does not get better

   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 salicylates 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.

OVERDOSAGE SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symtoms. 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 tablets with water every 4 hours while symptoms persist.
  • do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Hypromellose, Maltodextrin, Microcystalline Cellulose, Povidone, Polyethylene Glycol, Starch, Stearic Acid, Titanium Dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5526Backpirinv19f.jpg5526Backpirinv19f.jpg5526Backpirinv19f.jpg5526Backpirinv19f.jpg5526Backpirinv19f.jpg5526Backpirinv19f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283274acetaminophen 250 MG / caffeine 50 MG / magnesium salicylate 290 MG Oral TabletPSN2
884770BACKPRIN 250 MG / 50 MG / 290 MG Oral TabletPSN2
884770acetaminophen 250 MG / caffeine 50 MG / magnesium salicylate 290 MG Oral Tablet [Backprin]SBD2
283274acetaminophen 250 MG / caffeine 50 MG / magnesium salicylate 290 MG Oral TabletSCD2
283274APAP 250 MG / Caffeine 50 MG / Magnesium Salicylate 290 MG Oral TabletSY2
884770APAP 250 MG / Caffeine 50 MG / Magnesium Salicylate 290 MG Oral Tablet [Backprin]SY2
884770Backprin (acetaminophen 250 MG / caffeine 50 MG / magnesium salicylate 290 MG) Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0116BACKPRIN (ACETAMINOPHEN, CAFFEINE, SALICYLAMIDE) TABLET [HART HEALTH]2Legacy NDC20200607_a9301898-2c72-4ec0-bba1-1a2eb1962a38.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-011650332-0116-4, 50332-0116-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 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
5963362c-d180-49bd-be56-f2776ac7e746a9301898-2c72-4ec0-bba1-1a2eb1962a382020-06-05WarningsExact identifier
spl id: 5963362c-d180-49bd-be56-f2776ac7e746
spl set id: a9301898-2c72-4ec0-bba1-1a2eb1962a38

Reported adverse events (FAERS/openFDA)#

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