Label: IBUPROFEN PM- ibuprofen and diphenhydramine hcl capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 16, 2012

If you are a consumer or patient please visit this version.

  • 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, naproxin, 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.
  • 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 1-877-753-3935 Monday- Friday 9AM-5PM EST

  • Principal Display Panel

    †Compare to the active ingredients in Advil® PM LIQUI-GELS®

    IBUPROFEN PM SOFTGELS

    Solubilized Ibuprofen, 200 mg

    Diphenhydramine HCl, 25 mg

    PAIN RELIEVER (NSAID)/ NIGHTTIME SLEEP-AID

    †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 BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING


  • Product Label

    Best Choice Valu Merchandisers

    Ibuprofen PM softgels

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN PM 
    ibuprofen and diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-166
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUE (BLUE) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code IBUPM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-166-324 in 1 CARTON
    18 in 1 BLISTER PACK
    2NDC:63941-166-162 in 1 CARTON
    28 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09039706/10/2011
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)