ARTHRITEN INFLAMMATORY PAIN FORMULA- acetaminophen, aspirin, caffeine tablet, film coated

Arthriten by

Drug Labeling and Warnings

Arthriten by is a Otc medication manufactured, distributed, or labeled by Alva-Amco Pharmacal Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen, 250 mg

Aspirin, 250 mg (NSAID)*

Caffeine Anhydrous, 65 mg

*Non-steroidal anti-inflammatory drug

Purpose

Analgesic (pain reliever)

Analgesic (pain reliever)

Pain Reliever Aid

INDICATIONS & USAGE

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

WARNINGS

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

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 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 DOCTOR/PHARMACIST

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

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

PREGNANCY OR BREAST FEEDING

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

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 INGREDIENT

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

QUESTIONS

Questions?  1-800-792-2582

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTHRITEN  INFLAMMATORY PAIN FORMULA
acetaminophen, aspirin, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52389-237
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 K30 (UNII: U725QWY32X)
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: 52389-237-28	1 in 1 CARTON	07/23/2012
1	NDC: 52389-237-01	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	07/23/2012

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