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

  • NDC Code(s): 36800-756-40
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 28, 2022

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  • Active ingredient (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

    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

    • 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,  asthma or had a stroke 
    • 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

    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
    • you have symptoms of heart problems or stroke:
      • chest pain
      • trouble breathing
      • leg swelling
      • slurred speech
      • weakness in one part or side of body
    • pain gets worse or last 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 childlren 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
    • store at 20º to 25ºC (68º to 77ºF) 
    • avoid excessive heat above 40°C (104°F)
    • protect from light
    • swallow whole: do not crush, chew, or dissolve
    • read all warnings and directions before use. Keep carton.
  • Inactive ingredients

    D&C red #33, FD&C blue #1, gelatin, medium chain triglycerides, polyethylene glycol 600, potassium hydroxide, purified water, sorbitan, sorbitol

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO ADVIL®PM LIQUI-GELS® ACTIVE INGREDIENTS†

    NIGHTTIME

    Ibuprofen PM  Capsules

    PAIN RELIEVER (NSAID) • NIGHTTIME SLEEP-AID

    IBUPROFEN & DIPHENHYDRAMINE HCI 200 mg/25mg

    SOFTGELS**

    **Liquid-Filled Capsules

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® PM Liqui-Gels®.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    ©TOPCO PLVA0318

    topcare@topco.com

    www.topcarebrand.com

  • Product Packaging

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

    TOPCARE Ibuprofen 200 mg Softgels

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN PM 
    ibuprofen, diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-756
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 1007
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-756-401 in 1 BOX07/31/2018
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20088807/31/2018
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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