Your browser does not support JavaScript! SMART SENSE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [KMART CORPORATION]
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RxNorm Names

SMART SENSE IBUPROFEN PM (diphenhydramine citrate, ibuprofen) tablet, coated
[Kmart Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Advil® PM Caplets

Actual Size

IBUPROFEN PM

Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg

Pain Reliever (NSAID)/Nighttime Sleep-Aid

GLUTEN FREE

**CAPSULE-SHAPED TABLETS

SEE NEW WARNINGS INFORMATION

Ibuprofen PM Carton Image 1
Ibuprofen PM Carton Image 2
SMART SENSE IBUPROFEN PM 
diphenhydramine citrate, ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49738-191
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) 
FERROSOFERRIC OXIDE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULE (tablet) Size15mm
FlavorImprint Code L050
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-191-601 in 1 CARTON
120 in 1 BOTTLE
2NDC:49738-191-271 in 1 CARTON
280 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911305/27/2010
Labeler - Kmart Corporation (008965873)

Revised: 4/2013
 
Kmart Corporation

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