PAIN RELIEF PM- ibuprofen, diphenhydramine hcl capsule, liquid filled

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

MAH:

Bionpharma Inc.

administration_route:

ORAL

prescription_type:

OTC DRUG

therapeutic_indication:

Nighttime sleep-aid Pain reliever ■ for relief of occasional sleeplessness when associated with minor aches and pains ■ helps you fall asleep and stay asleep

authorization_status:

Abbreviated New Drug Application

SPC

PAIN RELIEF PM- IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
BIONPHARMA INC.
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_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH CAPSULE)_
Diphenhydramine hydrochloride 25 mg
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
_PURPOSES_
Nighttime sleep-aid
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: Ibuprofen 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: 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 h