PHARBETOL REGULAR STRENGTH- acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharbest Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

PHARBETOL REGULAR STRENGTH- ACETAMINOPHEN TABLET
PHARBEST PHARMACEUTICALS, 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._
----------
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Acetaminophen 325mg
PURPOSE
Pain reliever/fever reducer
USES
temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever
WARNINGS
LIVER WARNING: This product contains acetaminophen. The maximum daily
dose of this
product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets
(1,625 mg) in 24
hours for children.
Severe liver damage may occur if
adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours, which is the maximum daily
amount
taken with other drugs containing acetaminophen
adult has 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 in adults
pain gets worse or lasts more than 5 days in children under 12 years
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.
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