Label: ARTHRITEN MAX- acetaminophen, aspirin, caffeine tablet, film coated

  • NDC Code(s): 52389-337-28
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • 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 April 23, 2019

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

  • Active ingredients (in each caplet)

    Acetaminophen, 250 mg

    Aspirin (NSAID)*, 250 mg

    Caffeine Anhydrous, 65 mg

    *Non-steroidal anti-inflammatory drug

  • Purpose

    Analgesic (pain reliever)

    Analgesic (pain reliever)

    Pain Reliever Aid

  • Uses

    For the temporary relief of minor aches and pains including the minor pain of arthritis.

  • WARNINGS

    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:

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If skin 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 caplets in 24 hours, which is the maximum daily amount for this product.
    • with other products containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.

    Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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 (anti-coagulant) 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.
  • 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).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor.
  • ASK DOCTOR

    Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout or arthritis
    • taking any other drug.
  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • symptoms do not improve
    • pain or fever persists or gets worse
    • redness or swelling is present.
    • ringing in the ears or hearing loss occurs.
    • new symptoms occur
    • you experience any of the following signs of stomach bleeding:
      • you feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed 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 for children even if you do not notice any signs or symptoms.

  • Directions

    • Read all package directions and warnings before use. Use only as directed.
    • Adults:  Two (2) caplets every 6 hours while symptoms persist, not to exceed 4 doses (8 caplets) in 24 hours, or as directed by a doctor.
    • Drink a full glass of water with each dose
    • Intended for use by normally healthy adults only
    • Persons under 18 years of age should use only as directed by a doctor.
  • Other information

    **Contents sealed: Each ARTHRITEN white colored,  capsule shaped caplet bears the identifying mark "ALVA" and a "2" on the reverse side, and is packaged in a bottle with a safety seal under the cap.  Do not use if the seal appears broken or if product contents do not match product description.  You may report serious side effects to the phone number provided under Questions? below.

  • INACTIVE INGREDIENT

    Inactive ingredients: Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide and triglycerides.

  • QUESTIONS

    Questions?  1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    ArthritenMaxPDP

  • INGREDIENTS AND APPEARANCE
    ARTHRITEN  MAX
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-337
    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) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (capsule-shaped caplet) Size17mm
    FlavorImprint Code ALVA;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-337-281 in 1 CARTON08/24/2017
    128 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/24/2017
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)