ENTERIC COATED ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

McKesson Corporation dba SKY Packaging

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 325 mg in 325

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Do not use - if you are allergic to aspirin or any other pain reliever/fever reducer Stop use and ask a doctor if - you experience any of the following signs of stomach bleeding - feel faint have bloody or black stools vomit blood have stomach pain that does not get better - feel faint - have bloody or black stools - vomit blood - have stomach pain that does not get better - pain gets worse or lasts more than 10 days - fever gets worse or lasts more than 3 days - redness or swelling is present in the painful area - any new symptoms appear - ringing in the ears or a loss of hearing occurs Use for the temporary relief of minor aches and pains due to: headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor Pain Reliever

Product summary:

Product: 63739-523 NDC: 63739-523-01 30 TABLET, DELAYED RELEASE in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

Authorization status:

OTC monograph final

Summary of Product characteristics

ENTERIC COATED ASPIRIN REGULAR STRENGTH- ASPIRIN TABLET, DELAYED
RELEASE
MCKESSON CORPORATION DBA SKY PACKAGING
_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._
----------
331R ASA DR ORANGE TABS 325 MG
DO NOT USE
if you are allergic to aspirin or any other pain reliever/fever
reducer
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 cirrhosis, or
kidney disease
you are taking a diuretic
you have asthma
you have not been drinking fluids
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug for diabetes, gout, or arthritis
taking any other drug
under a doctor's care for any serious condition
STOP USE AND ASK A DOCTOR IF
you experience any of the following signs of stomach bleeding
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or a loss of hearing occurs
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not
to use aspirin during the last 3 months
of pregnancy unless definitely directed to do so 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.
DIRECTIONS
drink a full glass of water with each dose
adults and children 12 years and over: take 1 to 2 tablets every 4
hours while symptoms last. Do not
take more than 12 tablets in 24 hours unless directed by a doctor
children under 12 years: consult a doctor
OTHER INFORMATION
store at 25° C (77° F) excursions permitted between 15°-30° C
(