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ibuprofen pm (Rite Aid Corporation)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 1 BOTTLE in 1 CARTON (11822-0050-3) > 20 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (11822-0050-2) > 40 TABLET, COATED in 1 BOTTLE Label Information
TABLET, COATED 1 BOTTLE in 1 CARTON (11822-0050-1) > 80 TABLET, COATED in 1 BOTTLE Label Information

Complete ibuprofen pm Information

  • 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

    Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, asthma, or had a stroke
    • 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

    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
    • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
    • 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

    SEE NEW WARNINGS

    Compare to the active ingredients of Advil® PM Caplets

    ibuprofen PM

    ibuprofen and diphenhydramine citrate tablets, 200 mg/38 mg

    pain reliever (NSAID)/nighttime sleep-aid

    actual size

    80 CAPLETS†

    †capsule-shaped tablets

    ibuprofen PM image

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN PM 
    diphenhydramine citrate, ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0050
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code L050
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0050-1 1 in 1 CARTON 06/24/2009
    1 80 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:11822-0050-2 1 in 1 CARTON 03/19/2009
    2 40 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:11822-0050-3 1 in 1 CARTON 03/19/2009
    3 20 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:11822-0050-4 1 in 1 CARTON 05/14/2009
    4 30 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079113 03/19/2009
    Labeler - Rite Aid Corporation (014578892)