FDA Label for Naproxen Sodium And Diphenhydramine Hcl

View Indications, Usage & Precautions

ACTIVE INGREDIENT(S)
PURPOSE
USE(S)
WARNINGS
DO NOT USE
ASK A DOCTOR BEFORE USE IF
ASK A DOCTOR OR PHARMACIST BEFORE USE IF
WHEN USING THIS PRODUCT
STOP USE AND ASK DOCTOR IF
IF PREGNANT OR BREASTFEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS ?
PRINCIPAL DISPLAY PANEL

Naproxen Sodium And Diphenhydramine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Granules India Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because naproxen may, decrease this benefit of aspirin
• taking any other antihistamines
• taking any other drug

When Using This Product

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

Stop Use And Ask Doctor If

• you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• you have symptoms heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear
• you have difficulty swallowing
• it feels like the pill is stuck in your throat

If Pregnant Or Breastfeeding

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 caplets at bedtime
• do not take more than 2 caplets in 24 hours
• if taken with food, this product may take longer to work

Other Information

• read all warnings and directions before use.

• each caplet contains: sodium 20 mg
• store at 20 to 25°C (68 to 77°F).
• avoid high humidity and excessive heat above 40°C (104°F).

Tamper Evident: Do not use if foil inner seal under the cap is opened or missing

Inactive Ingredients

FD&C blue2 aluminum lake, hypromellose, magnesiumstearate, microcrystalline cellulose, polyethyleneglycol, povidone, talc, titanium dioxide.

Questions Or Comments ?

Contact 1-877-770-3183
Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

Naproxen Sodium and
Diphenhydramine HCl Tablets
220 mg/25 mg (NSAID)

Pain Reliever/Nighttime sleep-aid

SLEEP AID PLUS

12 HOUR PAIN RELIEVING

COMPARE TO THE ACTIVE INGREDIENTS OF ALEVE PM

20 Caplets ^†

†Capsule-Shaped Tablets