NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL- naproxen sodium and diphenhydramine 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 Amneal Pharmaceuticals NY LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

(in each tablet)

Diphenhydramine hydrochloride 25 mg

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

• Night time 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:

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 non-prescription 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 have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, 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 you are

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor's care for any serious condition
• 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 a 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 of 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 a 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 breast-feeding,

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 tablets at bedtime
• do not take more than 2 tablets in 24 hours
• if taken with food, this product may take longer to work

Other information

• each tablet contains: sodium 20 mg
• read all warnings and directions before use.
• store at 20° to 25°C (68° to 77°F)
• avoid high humidity and excessive heat above 40°C (104°F)

Inactive ingredients

carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

Questions or comments?

 1-877-835-5472 (Mon – Fri 9AM – 5PM EST)

Principal Display Panel

NDC: 69238-1422-6

Naproxen Sodium and Diphenhydramine HCl Tablets, 220 mg/25 mg

Rx only

160 Tablets

Amneal Pharmaceuticals LLC

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69238-1422
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	AC37
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69238-1422-2	1 in 1 CARTON	10/23/2018
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69238-1422-4	1 in 1 CARTON	10/23/2018
2		40 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69238-1422-8	1 in 1 CARTON	10/23/2018
3		80 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69238-1422-6	1 in 1 CARTON	10/23/2018
4		160 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209726	10/23/2018

Labeler - Amneal Pharmaceuticals NY LLC (123797875)