PHARBETOL- acetaminophen 500mg tablet, coated

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- ACETAMINOPHEN 500MG TABLET, COATED
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._
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 500mg
PURPOS E
Pain Reliever/fever reducer
US ES
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. Severe liver
damage may occur if you take
more than 8 caplets 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
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 the case of overdose, get medical help or contact a Poison Control
Center right away. (1-800-222-
1222)
DIRECTIONS
DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
adults and
children 12
years and over
take 2 caplets, every 6 hours
while symptoms last
do not take more than 6
caplets i