ALEVE PM- diphenhydramine hydrochloride and naproxen sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Available from:

Bayer HealthCare LLC.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for relief of occasional sleeplessness when associated with minor aches and pains - helps you fall asleep and stay asleep

Authorization status:

New Drug Application

Summary of Product characteristics

ALEVE PM- DIPHENHYDRAMINE HYDROCHLORIDE AND NAPROXEN SODIUM TABLET,
FILM
COATED
BAYER HEALTHCARE LLC.
----------
ALEVE PM
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPLET)_
_PURPOSES_
*
Diphenhydramine hydrochloride 25 mg
Nighttime sleep-
aid
Naproxen sodium 220 mg (naproxen 200 mg)
(NSAID)
Pain reliever
USES
for relief of occasional sleeplessness when associated with minor
aches and pains
helps you fall asleep and stay asleep
WARNINGS
ALLERGY ALERT
Naproxen sodium may cause a severe allergic reaction, especially in
people allergic to
aspirin. Symptoms may include:
hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters
If an allergic reaction occurs, stop use and seek medical help right
away.
STOMACH BLEEDING WARNING
This product contains an NSAID, which may cause severe stomach
bleeding. The chance
is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs
(aspirin,
ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed
HEART ATTACK AND STROKE WARNING
®
nonsteroidal anti-inflammatory drug
*
NSAIDs, except aspirin, increase the risk of heart attack, heart
failure, and stroke. These
can be fatal. The risk is higher if you use more than directed or for
longer than directed.
DO NOT USE
if you have ever had an allergic reaction to any other pain
reliever/fever reducer
unless you have time for a full night's sleep
in children under 12 years of age
right before or after heart surgery
with any other product containing diphenhydramine, even one used on
skin
if you have sleeplessness without pain
ASK A DOCTOR BEFORE USE IF
stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers
or fever
reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney