NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL tablet, film coated

Naproxen Sodium and Diphenhydramine HCl by

Drug Labeling and Warnings

Naproxen Sodium and Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

500 Caplets†

†Capsule-Shaped Tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL 
naproxen sodium and diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-814
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	G;17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-814-95	1 in 1 CARTON	02/20/2021
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62207-814-47	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2021
3	NDC: 62207-814-38	37500 in 1 POUCH; Type 0: Not a Combination Product	02/20/2021
4	NDC: 62207-814-39	7500 in 1 POUCH; Type 0: Not a Combination Product	02/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213663	02/20/2021

Labeler - Granules India Ltd (915000087)