BERKLEY AND JENSEN IBUPROFEN PM - diphenhydramine citrate and ibuprofen tablet, coated 
BJWC

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Active ingredient (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid

Pain reliever

Uses

Warnings

Allergy alert: Ibuprofen 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

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 a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have asthma
  • 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
  • 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
  • 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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Questions or comments? 

1-800-934-1204

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF ADVIL® PM

Ibuprofen PM

Ibuprofen & Diphenhydramine Citrate Tablets,200 mg/38 mg

Pain Reliever (NSAID)/Nighttime Sleep-Aid

**CAPSULE SHAPED TABLETS

SEE NEW WARNINGS INFORMATION

Ibuprofen PM Carton Image 1

Ibuprofen PM Carton Image 1

Ibuprofen PM Carton Image 2

Ibuprofen PM Carton Image 2


BERKLEY AND JENSEN IBUPROFEN PM 
diphenhydramine citrate, ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-050
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
GLYCERYL BEHENATE 
HYDROXYPROPYL CELLULOSE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScore no score
ShapeCAPSULE (tablet) Size15mm
FlavorImprint Code L050
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68391-050-481 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
1180 TABLET, COATED ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (68391-050-48)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911304/27/2009

Labeler - BJWC (159082692)

Revised: 03/2011 BJWC