ARTHRITEN MAX- acetaminophen, aspirin, caffeine 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 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

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:

Acetaminophen may cause severe skin reactions. Symptoms may include:

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

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

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

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

ArthritenMaxPDP

ARTHRITEN  MAX
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-337
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 250 mg
Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 250 mg
Inactive Ingredients
Ingredient Name Strength
Hypromelloses (UNII: 3NXW29V3WO)  
Maltodextrin (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Polydextrose (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
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
Color white Score no score
Shape CAPSULE (capsule-shaped caplet) Size 17mm
Flavor Imprint Code ALVA;2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52389-337-28 1 in 1 CARTON 08/24/2017
1 28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/24/2017
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 9/2017
Document Id: 5fb94370-15ae-45f3-9169-b2f4a94df820
Set id: db9d6424-09b5-4759-8ee0-8c18172b2c8f
Version: 1
Effective Time: 20170901
 
Alva-Amco Pharmacal Companies, Inc.