PAIN RELIEF PM- ibuprofen, diphenhydramine hcl capsule, liquid filled

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

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Active ingredient:
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)
Available from:
Bionpharma Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid Pain reliever ■ for relief of occasional sleeplessness when associated with minor aches and pains ■ helps you fall asleep and stay asleep
Authorization status:
Abbreviated New Drug Application
Authorization number:
69452-264-22

PAIN RELIEF PM- ibuprofen, diphenhydramine hcl capsule, liquid filled

Bionpharma Inc.

----------

Drug Facts

Active ingredients (in each capsule)

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purposes

Nighttime 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: Ibuprofen 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 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 continuing medical illness

■ taking any other antihistamines

■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

■ 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

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen 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

■ adults and children 12 years and over: take 2 capsules at bedtime

■ do not take more than 2 capsules in 24 hours

Other information

each capsule contains:potassium 20 mg

■ read all warnings and directions before use.

■ store at 20° to 25°C (68° to 77°F)

■ avoid excessive heat above 40°C (104°F)

■ protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide,

purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-888-235-2466

Manufactured for:

Bionpharma Inc.

600 Alexander Road

Princeton, NJ 08540

All trademarks are property of their respective owners. This product is not affiliated with the

makers/owners of Advil

PM LIQUI-GELS .

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH

“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

R0319

L0000084

Principal Display Panel

compare to the active ingredients in Advil

PM Liqui-Gels

NDC 69452-264-22

a+health

pain relief pm

solubilized ibuprofen, 200 mg/diphenhydramine HCl, 25 mg

pain reliever (NSAID)/nighttime sleep-aid

120 capsules**

**liquid-filled capsule

FRONT

BACK

PAIN RELIEF PM

ibuprofen, diphenhydramine hcl capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 452-26 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

IBUPRO FEN (UNII: WK2XYI10 QM) (IBUPROFEN - UNII:WK2XYI10 QM)

IBUPROFEN

20 0 mg

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

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

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

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GELATIN (UNII: 2G8 6 QN327L)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

Product Characteristics

Color

BLUE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

IBUPM

Contains

Bionpharma Inc.

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 452-26 4-22

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

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 39 7

0 5/0 1/20 19

Labeler -

Bionpharma Inc. (079637826)

Registrant -

Bionpharma Inc. (079637826)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Patheo n So ftgels Inc.

0 0 219 38 29

ma nufa c ture (6 9 452-26 4)

Revised: 4/2019

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