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), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Available from:

Harmon Store Inc.

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 500 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever Nighttime sleep-aid temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEVER PM EXTRA STRENGTH- ACETAMINOPHEN, DIPHENHYDRAMINE
HCL TABLET, FILM COATED
HARMON STORE 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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CORE VALUES 44-235-DELISTED
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
_PURPOSE_
Pain reliever
Nighttime sleep-aid
USES
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 product containing diphenhydramine, even one used on
skin
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.
if you have ever had an allergic reaction to this product or any of
its ingredients
ASK A DOCTOR BEFORE USE IF YOU HAVE
a breathing problem such as emphysema or chronic bronchitis
liver disease
glaucoma
difficulty in urination due to enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
WHEN USING THIS PRODUCT
avoid alcoholic beverages
drowsiness will occur
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.
new symptoms occur
redness or swelling is present
pain gets worse o