Arthriten

Manufacturer
Alva-Amco Pharmacal Companies, Inc.
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:02:33

Label at a glance#

ProductArthriten Max
Active ingredientACETAMINOPHEN, CAFFEINE, ASPIRIN
Label structure15 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, 250 mg

Aspirin (NSAID)*, 250 mg

Caffeine Anhydrous, 65 mg

*Non-steroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Analgesic (pain reliever)

Analgesic (pain reliever)

Pain Reliever Aid

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

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).  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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

INFORMATION FOR PATIENTS SECTION

**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 SECTION

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

OTC - QUESTIONS SECTION

Questions?  1-800-792-2582

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ArthritenMaxPDPArthritenMaxPDP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-337ARTHRITEN MAX (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]8Legacy NDC20240517_db9d6424-09b5-4759-8ee0-8c18172b2c8f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-33752389-337-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

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
47d465e9-b238-020b-e063-6394a90a0771db9d6424-09b5-4759-8ee0-8c18172b2c8f2026-01-07WarningsExact identifier
spl set id: db9d6424-09b5-4759-8ee0-8c18172b2c8f

Reported adverse events (FAERS/openFDA)#

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