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Name:Arthritenjoint Pain Relief
Manufacturer:Alva-amco Pharmacal Companies, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ARTHRITEN JOINT PAIN RELIEF - acetaminophen, caffeine and magnesium salicylate tablet, film coated 
Alva-Amco Pharmacal Companies, Inc.

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.

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Drug Facts

Active ingredients (in each tablet)

Acetaminophen, 250 mg................................................Analgesic (pain reliever)

Caffeine Anhydrous, 32.5 mg.........................................Pain Reliever Aid

Magnesium Salicylate Tetrahydrate (NSAID)*, 310 mg.....Analgesic (pain reliever)

(equivalent to 250 mg Magnesium Salicylate)

*Non-steroidal anti-inflammatory drug

Uses

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

Warnings

Reye's Syndrome: Children and teenagers should not use this product for chicken pox or flu symptoms before a doctor is consulted about Reye's Syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Magnesium Salicylate 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 pills 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.
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.

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.
  • 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.

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) tablets every 6 hours while symptoms persist, not to exceed 4 doses (8 tablets) 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

Magnesium content: 30 mg/tablet **Contents sealed: Arthriten Joint Pain Relief white colored, oval (football) shaped tablets bear the identifying mark "ALVA" and a '1" on the reverse side, and are packaged in a bottle with a safety seal under the cap.  Do not use if the seal appears broken or if product doesn't match product description.  You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium carbonate, magnesium oxide, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide, triacetin.

Questions?  1-800-792-2582

Arthriten PDP


ARTHRITEN  JOINT PAIN RELIEF
acetaminophen, caffeine, magnesium salicylate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-137
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 250 mg
Caffeine (Caffeine) Caffeine 32.5 mg
Magnesium salicylate (Salicylic acid) Magnesium salicylate 310 mg
Inactive Ingredients
Ingredient Name Strength
Calcium carbonate  
Croscarmellose sodium  
Hypromellose  
Magnesium carbonate  
Magnesium oxide  
Magnesium stearate  
Cellulose, microcrystalline  
Mineral oil  
Povidone  
Silicon Dioxide  
Sodium lauryl sulfate  
Sodium starch glycolate type a potato  
Starch, corn  
Stearic acid  
Talc  
Titanium dioxide  
Triacetin  
Product Characteristics
Color white Score no score
Shape OVAL Size 15mm
Flavor Imprint Code ALVA;1
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52389-137-80 1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC (52389-137-01)
1 NDC:52389-137-01 80 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (52389-137-80)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 10/28/2002

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010 Alva-Amco Pharmacal Companies, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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