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Arthriten Inflammatory Pain Formula

Dosage form: tablet, film coated
Ingredients: Acetaminophen 250mg, Caffeine 65mg, Aspirin 250mg
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-237

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 Facts

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)

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

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

  • 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 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 a doctor or pharmacist before use if you are
  • taking a prescription drug for diabetes, gout or arthritis
  • taking any other drug.

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

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

Questions?  1-800-792-2582

ARTHRITEN  INFLAMMATORY PAIN FORMULA
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-237
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Caffeine (Caffeine) Caffeine65 mg
Aspirin (Aspirin) Aspirin250 mg
Inactive Ingredients
Ingredient NameStrength
Hypromelloses 
Maltodextrin 
CELLULOSE, MICROCRYSTALLINE 
Polydextrose 
POVIDONE 
STARCH, CORN 
silicon dioxide 
stearic acid 
talc 
Titanium Dioxide 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (capsule-shaped caplet) Size17mm
FlavorImprint CodeALVA;2
Contains    
Packaging
#Item CodePackage Description
1NDC:52389-237-281 BOTTLE, PLASTIC in 1 CARTON
1NDC:52389-237-0128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/23/2012
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 07/2015
 
Alva-Amco Pharmacal Companies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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