Naproxen Sodium And Diphenhydramaine Hcl Tablets

Naproxen Sodium And Diphenhydramaine Hcl Tablets
SPL v5
SPL
SPL Set ID 0d59780a-ef22-4b67-8b42-9795dbec8db0
Route
ORAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Hypromellose 2910 (3 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol Povidone Talc Titanium Dioxide Hypromellose 2910 (6 Mpa.s) Fd&c Blue No. 2--aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: G;17 Shape: capsule Color: blue Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2021-02-20

Description

Diphenhydramine Hydrochloride 25 mg Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)* * nonsteroidal anti-inflammatory drug

Purpose

Night time sleep aid Pain reliever


Medication Information

Purpose

Night time sleep aid

Pain reliever



Description

Diphenhydramine Hydrochloride 25 mg Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)* * nonsteroidal anti-inflammatory drug

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.

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

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

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
Active Ingredient(s)

Diphenhydramine Hydrochloride 25 mg

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

* nonsteroidal anti-inflammatory drug

Inactive Ingredients

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

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

Questions Or Comments ?

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.

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

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

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.

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


Structured Label Content

Use(s) (USE(S))
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
Purpose (PURPOSE)

Night time sleep aid

Pain reliever



Warnings (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.

Directions (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

Do Not Use (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

Other Information (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
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Diphenhydramine Hydrochloride 25 mg

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

* nonsteroidal anti-inflammatory drug

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Principal Display Panel (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

Questions Or Comments ? (QUESTIONS OR COMMENTS ?)

Contact 1-877-770-3183

Mon-Fri 8:00 AM EST to 5:00 PM PST.

When Using This Product (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

Ask A Doctor Before Use If (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

Stop Use and Ask Doctor If (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 (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 (KEEP OUT OF REACH OF CHILDREN)


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

Ask A Doctor Or Pharmacist Before Use If (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


Advanced Ingredient Data


Raw Label Data

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