Label: BACKPRIN- acetaminophen, caffeine, salicylamide tablet

  • NDC Code(s): 50332-0116-2, 50332-0116-4
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 5, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (in each tablet):

    Acetaminophen 250 mg

    Caffeine 50 mg

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

  • PURPOSE

    Purpose:

    Pain Reliever/Fever Reducer

    Pain Reliever Aid

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor back pain

  • WARNINGS

    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)

  • DO NOT USE

    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)
  • ASK DOCTOR

    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
  • STOP USE

    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.

  • PREGNANCY OR BREAST FEEDING

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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

    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

    Inactive Ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    5526Backpirinv19f.jpg5526Backpirinv19f.jpg5526Backpirinv19f.jpg

  • INGREDIENTS AND APPEARANCE
    BACKPRIN 
    acetaminophen, caffeine, salicylamide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0116-450 in 1 BOX, UNIT-DOSE07/14/2000
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0116-2125 in 1 BOX, UNIT-DOSE07/14/2000
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/14/2000
    Labeler - HART Health (069560969)