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Ibuprofen PM (TOP CARE (Topco Associates LLC))

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 4 BLISTER PACK in 1 CARTON (36800-165-32) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Ibuprofen PM Information

  • Active Ingredients (in each capsule)

    Diphenhydramine hydrochloride 25 mg

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
    (present as the free acid and potassium salt)
    *non-steroidal anti-inflammatory drug


  • Purpose

    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:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDS [aspirin, ibuprofen, naproxen, or others]
    • take more or for a longer time than directed.
    • have 3 or more alcoholic drinks every day while using this product

    Do not use
    • in children under 12 years of age
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
    • unless you have time for a full night’s sleep
    • with any other product containing diphenhydramine , even one used on skin
    • if you have sleeplessness without pain

    Ask a doctor before use if
    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have glaucoma
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers.
    • you have a breathing problem such as emphysema or chronic bronchitis
    • 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
    • taking any other drug
    • taking any other antihistamines
    • taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
    • under a doctor's care for any continuing medical illness

    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
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
      • pain gets worse or last more than 10 days
      • sleepnessness 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 of 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


  • Directions

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

    Other information
    • each capsule contains:potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20°-25°C (68°-77° F)
    • avoid high humidity and excessively heat above 40o C (104o F)
    • protect from light.

  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20º to 25ºC (68º to 77ºF)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • protect fron light

  • Inactive Ingredients

    FD&C Blue #1, FD&C Red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan,sorbitol


  • Questions or comments?

    call toll free 1-888-423-0139


  • Principal Display Panel

    SOFTGELS

    Ibuprofen PM

    IBUPROFEN, 200 mg

    Pain Reliever (NSAID)

    Diphenhydramine HCl, 25 mg

    Nighttime Sleep-Aid

    SOFTGELS**

    (**LIQUID FILLED CAPSULES)

    COMPARE TO ADVIL® PM LIQUI-GELS® active ingredients†

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.comwww.topcarebrand.com



  • Product Label

    Diphenhydramine Hydrochloride 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

    TOPCARE Ibuprofen PM


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN PM 
    ibuprofen and diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-165
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code IBUPM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-165-32 4 in 1 CARTON 09/22/2011
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:36800-165-40 1 in 1 BOX 09/22/2011
    2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090397 09/22/2011
    Labeler - TOP CARE (Topco Associates LLC) (006935977)