EXTRA STRENGTH ACETAMINOPHEN PM- acetaminophen and diphenhydramine hydrochloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

זמין מ:

Spirit Pharmaceutical LLC

INN (שם בינלאומי):

ACETAMINOPHEN

הרכב:

ACETAMINOPHEN 500 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

OTC DRUG

סממני תרפויטית:

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

מצב אישור:

OTC monograph not final

מאפייני מוצר

EXTRA STRENGTH ACETAMINOPHEN PM- ACETAMINOPHEN AND
DIPHENHYDRAMINE HYDROCHLORIDE TABLET
SPIRIT PHARMACEUTICAL LLC
_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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EXTRA STRENGTH ACETAMINOPHEN PM
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_CAPLET)_
_PURPOSE_
Acetaminophen 500mg
Pain reliever
Diphenhydramine HCl 25mg
Nighttime Sleep aid
USES
for the temporary relief of occasional headaches and minor aches and
pains with
accompanying sleeplessness
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur
with this product
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 you are 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 other products containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains acetaminophen, ask a doctor
or
pharmacist
in children under 12 years of age
with any other products containing diphenhydramine, even one used on
skin
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
breathing problems such as emphysema or chronic bronchitis
trouble urinating due to an enlargement of the prostate gland
glaucoma
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery.
STOP USE AND ASK A DOCTOR IF
sleeplessness persists continuously for more than 2 weeks. Insomnia
may be a
symptom of a serious underlying medical illness
pain gets worse