TOPCARE ALL NIGHT PAIN RELIEF PM- diphenhydramine hydrochloride, naproxen sodium tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)
Available from:
Topco Associates LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid Pain reliever
Authorization status:
Abbreviated New Drug Application
Authorization number:
36800-264-27, 36800-264-60

TOPCARE ALL NIGHT PAIN RELIEF PM- diphenhydramine hydrochloride, naproxen

sodium tablet, film coated

Topco Associates LLC

----------

Topco Associates LLC. All Night Pain Relief PM Drug Facts

Active ingredients (in each caplet)

Diphenhydramine hydrochloride 25 mg

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

*nonsteroidal anti-inflammatory drug

Purpos es

Nighttime sleep-aid

Pain reliever

Us es

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to

aspirin. Symptoms may include:

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:

for relief of occasional sleeplessness when associated with minor aches and pains

helps you fall asleep and stay asleep

hives

facial swelling

asthma (wheezing)

shock

skin reddening

rash

blisters

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 you use more than directed or for longer

than directed.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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, 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

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

drowsiness will occur

avoid alcoholic drinks

do not drive a motor vehicle or operate machinery

take with food or milk if stomach upset occurs

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

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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium

stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide,

talc, titanium dioxide

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO ALEVE pm

ACTIVE INGREDIENTS

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

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

read all warnings and directions before use. Keep outer carton.

each caplet contains: sodium 21 mg

store at 20-25°C (68-77°F)

avoid high humidity and excessive heat above 40°C (104°F

All Night Pain Relief PM

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE TABLETS, 220 mg / 25

PAIN RELIEVER (NSAID) – NIGHTTIME SLEEP-AID

OUR PHARMACISTS RECOMMEND

Sleep Aid Plus 12- Hour Pain Reliever

80 CAPLETS†

†CAPSULE-SHAPED TABLETS

actual size

TOPCARE ALL NIGHT PAIN RELIEF PM

diphenhydramine hydrochloride, naproxen sodium tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -26 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

NAPRO XEN SO DIUM (UNII: 9 TN8 7S3A3C) (NAPROXEN - UNII:57Y76 R9 ATQ)

NAPROXEN SODIUM

220 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

Imprint Code

L26 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:36 8 0 0 -26 4-6 0

1 in 1 CARTON

0 8 /0 8 /20 19

1

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:36 8 0 0 -26 4-27

1 in 1 CARTON

0 8 /12/20 19

2

8 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Topco Associates LLC

ANDA

ANDA20 8 49 9

0 8 /0 8 /20 19

Labeler -

T opco Associates LLC (006935977)

Revised: 8/2019

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