HENRY SCHEIN ACETAMINOPHEN- acetaminophen tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Henry Schein, Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 325 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Pain reliever/fever reducer Uses temporarily relieves minor aches and pains due to: - headache - muscular aches - minor pain of arthritis - backaghe - the common cold - toothache - premenstral and menstrual cramps temporarily reduces fever Stop use and ask a doctor if - pain gets worse or lasts for more than 10 days - fever gets worse or lasts more than 3 days - new symptoms occur - redness or swelling is present These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HENRY SCHEIN ACETAMINOPHEN- ACETAMINOPHEN TABLET, FILM COATED
HENRY SCHEIN, 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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HENRY SCHEIN ACETAMINOPHEN
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH TABLET)_
Acetaminophen 325 mg
_PURPOSE_
Pain reliever/fever reducer
_USES_
temporarily relieves minor aches and pains due to:
headache
muscular aches
minor pain of arthritis
backaghe
the common cold
toothache
premenstral 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 in 24 hours, which is the maximum daily amount
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 for more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
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.
OVERDOSE WARNING: In case of overdose, get medical help or contact a
Poison Control
Center right away (1-800-222-1222). Quick medical attention is
critical for adults as well
as for children even if you do not notice any signs or sy