Arthriten

Alva-Amco Pharmacal Companies, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients (in each caplet)
• Purpose
• Directions
• Arthriten Other information

FULL PRESCRIBING INFORMATION

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

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

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
  
• with other products containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

• 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.

• 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.

• 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

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

• an allergic reaction occurs. Seek medical help right away.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present.
• ringing in the ears or hearing loss occurs.
• any 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.

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.

Arthriten 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