SMART SENSE IBUPROFEN PM- diphenhydramine citrate, ibuprofen tablet, coated

Drug Details [pdf]

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?

1-800-719-9260
Principal Display Panel

COMPARE TO ACTIVE INGREDIENTS IN ADVIL® PM CAPLETS

Ibuprofen PM

Ibuprofen and Diphenhydramine Citrate Tablets, 200 mg/38 mg

ACTUAL SIZE

PAIN RELIEVER (NSAID) / NIGHTTIME SLEEP-AID

COATED CAPLETS**

20 CAPLETS**

**CAPSULE-SHAPED TABLETS

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INGREDIENTS AND APPEARANCE

SMART SENSE IBUPROFEN PM
diphenhydramine citrate, ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-191
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE CITRATE	38 mg
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL (UNII: 532B59J990)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE (tablet)	Size	15mm
Flavor		Imprint Code	L050
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 49738-191-60	1 in 1 CARTON	06/04/2010
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49738-191-27	1 in 1 CARTON	05/27/2010
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49738-191-76	1 in 1 CARTON	04/29/2017
3		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079113	05/27/2010

Labeler - Kmart Corporation (008965873)

SMART SENSE IBUPROFEN PM- diphenhydramine citrate, ibuprofen tablet, coated

smart sense ibuprofen pm by

Drug Labeling and Warnings

Drug Details [pdf]

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.