ACETAMINOPHEN tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

COSTCO WHOLESALE CORPORATION

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer - temporarily relieves minor aches and pains due to: backache the common cold muscular aches headache toothache minor pain of arthritis premenstrual and menstrual cramps - backache - the common cold - muscular aches - headache - toothache - minor pain of arthritis - premenstrual and menstrual cramps - temporarily reduces fever

Authorization status:

OTC monograph not final

Summary of Product characteristics

ACETAMINOPHEN- ACETAMINOPHEN TABLET, COATED
COSTCO WHOLESALE CORPORATION
_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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KIRKLAND 44-519-ACETAMINOPHEN
_ACTIVE INGREDIENT (IN EACH GELCAP)_
Acetaminophen 500 mg
_PURPOSE_
Pain reliever/fever reducer
_USES_
temporarily relieves minor aches and pains due to:
backache
the common cold
muscular aches
headache
toothache
minor pain of arthritis
premenstrual and menstrual cramps
temporarily reduces fever
_WARNINGS_
LIVER WARNING: This product contains acetaminophen. Severe liver
damage may occur if
you take
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms
may
include:
skin reddening
blisters
rash
If a skin reaction occurs, stop use and seek medical help right away.
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist.
if you are allergic to acetaminophen or any of the inactive
ingredients in this product
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin.
STOP USE AND ASK A DOCTOR IF
pain gets worse or lasts more than 10 days
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
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_
DO NOT TAKE MORE THAN DIRECTED
adults and children