PAIN RELIEF PM- acetaminophen and diphenhydramine hydrochloride tablet, coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
05-09-2019

Virkt innihaldsefni:

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

Fáanlegur frá:

Meijer

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

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

Leyfisstaða:

OTC monograph final

Vara einkenni

                                PAIN RELIEF PM- ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
TABLET, COATED
MEIJER
_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._
----------
MEI-1095-2019-0904
_DRUG FACTS_
_ACTIVE INGREDIENTS _
_(IN EACH CAPLET)_
_PURPOSE_
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime
sleep aid
US ES
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 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.
with any other product containing diphenhydramine, even one used on
skin
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF YOU HAVE
liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged 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 serious
underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelli
                                
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