NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Granules India Ltd

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

OTC DRUG

Indikazzjonijiet terapewtiċi:

Night time sleep aid Pain reliever - for relief of occasional sleeplessness when associated with minor aches and pains - helps you fall asleep and stay asleep • 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 • 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 disease, asthma, Drug Facts Drug Facts or had a stroke • you are taking a diuretic • you have a breathing p

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL- NAPROXEN SODIUM AND
DIPHENHYDRAMINE HCL TABLET, FILM COATED
GRANULES INDIA LTD
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NAPROXEN SODIUM AND DIPHENHYDRAMAINE HCL TABLETS
ACTIVE INGREDIENT(S)
Diphenhydramine Hydrochloride 25 mg
Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*
* nonsteroidal anti-inflammatory drug
PURPOSE
Night time sleep aid
Pain reliever
USE(S)
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:
NSAIDs, except aspirin, increase the risk of heart attack, heart
failure, and stroke. These
can be fatal. The risk is higher if 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 hist