Label: FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF- acetaminophen magnesium salicylate tablet

  • NDC Code(s): 42961-111-81, 42961-111-83
  • Packager: Cintas Corporation
  • 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 March 24, 2021

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

  • Purpose(s)

    Active ingredients (in each tablet)

    Acetaminophen 250 mg.........pain reliever/fever reducer

    Magnesium salicylate 290mg (NSAID*)..pain reliever/fever reducer

    Caffeine 50mg......................adjuvant/alertness aid

    *Nonsteroidal anti-inflammatory drug

  • Active Ingredients

    Active ingredients (in each tablet)
    • Acetaminophen 250mg…………………………………….pain reliever/fever reducer
    • Magnesium Salicylate 290mg (NSAID*)………………….pain reliever/fever reducer
    • Caffeine 50mg……………………………………………..adjuvant/alertness aid

  • Inactive Ingredients

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

  • Uses

    Temporarily relieves minor aches and pains associated with:

    • Muscular aches
    • Backache
  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
    Allergy alert: Allergy alert: Magnesium Salicylate may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may
    include: ■ hives ■ asthma (wheezing) ■ facial swelling ■ shock ■ skin reddening ■ rash ■ blisters
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
    ■ more than 8 tablets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product.
    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.
    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
    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
    Do not use
    ■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to aspirin or salicylates ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ for children under 3 years of age unless directed by a doctor
    Ask a doctor before use if ■ stomach bleeding warning applies to you
    ■ you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease ■ you are taking a diuretic ■ you have a history of stomach problems, such as heartburn
    Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ anticoagulation (thinning of the blood) ■ diabetes ■ gout ■ arthritis
    When using this product do not exceed recommended dose.
    Stop use and ask doctor if
    ■ you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    ■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs
    If pregnant or breast-feeding, ask a health professional before use.
    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 required for adults as well as children even if you do not notice any signs or symptoms.

  • 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 required for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children 12 years and older: Take 1 to 2 tablets every 6 hours while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.
    Children under 12 years of age: Ask a doctor

  • Other Information

    ■ do not use if packet is torn, cut or opened ■ store at room temperature ■ avoid excessive heat and humidity
    Questions? 1-800-327-2704
    80 Tablets/2 Tablets per Packet

  • First Aid Direct (FAD) Backache and Muscle Relief

    Backache and Muscle Relief

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT BACKACHE AND MUSCLE RELIEF 
    acetaminophen magnesium salicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE290 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:42961-111-8380 in 1 BOX03/25/2021
    1NDC:42961-111-812 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/25/2021
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    UltraTab Laboratories151051757manufacture(42961-111)