Label: ARAMARK BACK RELIEF- magnesium salicylate tablet

  • NDC Code(s): 81238-1118-1
  • Packager: Western First Aid Safety DBA Aramark
  • 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 24, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)
    Acetaminophen 250 mg
    Cafeine 50mg
    *Nonsteroidal anti-inflammatory drug
    Magnesium Salicylate (NSAID) 290 mg

  • PURPOSE

    Purpose
    Acetaminophen ....Pain Reliever/Fever Reducer
    Cafeine .........................................Adjuvent
    *Nonsteroidal anti-inflammatory drug
    Magnesium Salicylate (NSAID) ......Pain Reliever

  • INDICATIONS & USAGE

    Uses:
    Temporarily Relieves minor aches and pains
    associated with: • back pain • muscular aches

  • 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 aspirin.

    Allergy Alert: Saticylates (NSAIDs) may cause a severe
       allergic reaction which may include: • hives • shock
       • facial swelling • asthma (wheezing)

    If a skin or allergic reaction occurs, stop use
    and seek medical help right away.

    Liver Warning: This product contains acetaminophen.
       Severe liver damage may occur if you take:
       • more than 8 tablets in 24 hours
       • with other drugs containing acetaminophen
      (prescription or nonprescription)
       • Ask a doctor or pharmacist before using with
      other drugs if you are not sure.
       • 3 or more alcoholic drinks every day while using
       this product.
    Stomach Bleeding Warning: This product contains
       nonsteroidal anti-inflammatory drugs (NSAIDs),
       which may cause 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 an NSAID (aspirin,
         ibuprofen, naproxen, or others)
       • take more or for a longer time than directed

    Do not use:
       • with any other pain reliever/fever reducer
       • for pain for more than 10 days or for fever for
         more than 3 days unless directed by a doctor
       • with any other product containing
         acetaminophen
       • right before or after heart surgery

    Ask a doctor before using if you have:
    • upset stomach or stomach pain • ulcers
    • bleeding problems • high blood pressure • heart or
      kidney disease • taken a diuretic • reached age 60
      or older

    Ask a doctor or pharmacist before use if you are:
    • taking any other drug containing an NSAID
    (prescription or nonprescription)
    • taking a blood thinning (anticoagulant) or
    steroid drug

    When using this product do not exceed the
    recommended dose.

    Caffeine warning: The recommended dose of this
    product contains about as much caffeine as a cup of coffee.
    Limit the use of careline-containing medications, foods, or
    beverages while taking this product because too much careline
    may cause nervousness, irritability, sleeplessness, and,
    occasionally, rapid heartbeat.

    Stop use and ask a doctor if:
    • ringing in the ears or loss of hearing occurs
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present
    • you feel faint, vomit blood, or have bloody or
      black stools.
    • These are signs of stomach bleeding.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health
    professional before use. IT IS ESPECIALLY
    IMPORTANT NOT TO USE ASPIRIN DURING THE
    LAST 3 MONTHS OF PREGNANCY UNLESS
    SPECIFICALLY 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 right away. Prompt medical
    attention is critical for adults as well as children
    even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions:
    • Adults and
    children 12 years
    of age and older:

    2 tablets as
    needed for pain
    every 4 hours. Do
    not exceed 8 tablets
    in 24 hours or as
    directed by a doctor.

    • Children under
    12 years:
    Do not give to
    children under 12 years
    of age

  • OTHER SAFETY INFORMATION

    Other Information:
    • read all product information before using
    • store at room temperature 59°-86°F (15°-30°C)
    • avoid excessive heat and humidity
    • tamper-evident sealed packets
    • do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    hypromellose, maltodextrin, microcrystalline
    cellulose, polyethylene glycol, povidone,
    starch 1551, stearic acid, titanium dioxide

  • Product Labeling

    aramark

    100 Tablets                        Part # 07333

    Per Box

    Back Relief

    Pain Reliever/Fever Reducer

    MANUFACTURED FOR:

    Aramark
    Lenexa, KS 66219
    (866) 362-2691

    aramarkuniform.com

    Retain carton for complete product information

    100 Tablet Box

    1118 100 Tab Cartn

    2-tablet Packet

    1118 2 Ct Paket

  • INGREDIENTS AND APPEARANCE
    ARAMARK BACK RELIEF 
    magnesium salicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-1118
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-1118-150 in 1 BOX06/14/2021
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/14/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(81238-1118)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION944090448manufacture(81238-1118)