ARTHRITEN MAX- acetaminophen, aspirin, caffeine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

Alva-Amco Pharmacal Companies, Inc.

INN (International Name):

Acetaminophen

Composition:

Acetaminophen 250 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Analgesic (pain reliever) Analgesic (pain reliever) Pain Reliever Aid For the temporary relief of minor aches and pains including the minor pain of arthritis. 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. 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 - you feel faint - vomit blood - have bloody or blac

Authorization status:

OTC monograph not final

Summary of Product characteristics

ARTHRITEN MAX- ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED
ALVA-AMCO PHARMACAL COMPANIES, INC.
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ARTHRITEN MAX
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:
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