Pill Identifier App

berkley and jensen ibuprofen pm

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE CITRATE 38mg, IBUPROFEN 200mg
Labeler: BJWC
NDC Code: 68391-050

BJWC Ibuprofen PM Drug Facts

Active ingredients (in each caplet)

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*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

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, or asthma
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
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. (1-800-222-1222)

Directions
do not take more than directed
adults and children 12 years and over: take 2 caplets at bedtime
do not take more than 2 caplets in 24 hours

Other information
read all warnings and directions before use. Keep carton.
store at 20-25°C (68 -77°F)
avoid excessive heat above 40°C (104°F)

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

PAIN RELIEVER/NIGHTTIME SLEEP-AID

IBUPROFEN PM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLETS, 200 mg/38 mg PAIN RELIEVER (NSAID) / NIGHTTIME SLEEP-AID

See New Warnings Information

Compare to the active ingredients of Advil® PM Caplets

180 COATED CAPLETS**

**CAPSULE-SHAPED TABLETS

GLUTEN FREE

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
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
GLYCERYL DIBEHENATE 
HYDROXYPROPYL CELLULOSE (TYPE H) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ALCOHOL 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULE (tablet) Size15mm
FlavorImprint CodeL050
Contains    
Packaging
#Item CodePackage Description
1NDC:68391-050-481 BOTTLE in 1 CARTON
1180 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911304/27/2009
Labeler - BJWC (159082692)

Revised: 12/2013
 
BJWC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)