IBUPROFEN PM- diphenhydramine hydrochloride, ibuprofen capsule, liquid filled

Ibuprofen PM by

Drug Labeling and Warnings

Ibuprofen PM by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, LNK International, Inc., Strides Arcolab Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Purpose

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:

• facial swelling
• blisters
• hives
• rash
• skin reddening
• shock
• asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 

Do not use

• if you have sleeplessness without pain
• 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
• with any other product containing diphenhydramine, even one used on skin
• right before or after heart surgery

Ask a doctor before use if

• you are taking a diuretic
• if 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, or asthma
• you have glaucoma
• you have a breathing problem such as emphysema or chronic bronchitis
• stomach bleeding warning applies to you
• 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 any other drug
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
• 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. Keep carton.
• store at 20º-25ºC (68º-77ºF)
• protect from light
• avoid excessive head above 40ºC (104ºF)

Inactive ingredients

anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, hydrolysed gelatin, medium chain triglyceride, opacode white ink, polyethylene glycol 600, potassium hydroxide, purified water.
Ingredients of opacode white ink: lecithin (soya), n-butyl alcohol, purified water, shellac glaze in ethanol, simethicone and titanium dioxide.

Questions or comments?

Call 1-800-426-9391
8:30 AM-4:00PM ET, Monday-Friday

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡

NDC: 0363-0611-21

Ibuprofen PM
Ibuprofen 200 mg /
Pain Reliever (NSAID)
Diphenhydramine HCl 25 mg /
Nighttime Sleep Aid

NIGHTTIME

16 SOFTGELS

Compare to Advil® PM LIQUI-GELS® active ingredientsⱡⱡ

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

ⱡWalgreens Pharmacist Survey Study, November 2012.
ⱡⱡThis product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.
50844    ORG111261121

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD.,  DEERFIELD, IL 60015
WALGREENS
100 % SATISFACTION GUARANTEED
walgreens.com ©2013 Walgreen Co.
PRODUCT OF INDIA

 

Walgreens 44-611

INGREDIENTS AND APPEARANCE

IBUPROFEN PM 
diphenhydramine hydrochloride, ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0611
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHELLAC (UNII: 46N107B71O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE (bluish purple)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	1007
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0611-21	2 in 1 CARTON	07/08/2013	09/12/2021
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200888	07/08/2013	09/12/2021

Labeler - Walgreen Company (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0611)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Arcolab Limited		918513263	API MANUFACTURE(0363-0611)