SUNMARK PAIN RELIEVER PM EXTRA STRENGTH acetaminophen diphenhydramine hcl tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

McKesson

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNMARK PAIN RELIEVER PM EXTRA STRENGTH- ACETAMINOPHEN,
DIPHENHYDRAMINE
HCL TABLET, FILM COATED
MCKES S ON
_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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MCKESSON PAIN RELIEVER PM DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPLET)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
PURPOS E
Pain reliever
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
DO NOT USE
in children under 12 years of age
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
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
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking sedatives or tranquilizers
taking the blood thinning drug warfarin
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 lasts 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 swelling is present
new symptoms occur
These could be signs of a serious condition.
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH