Label: EQUALINE IBUPROFEN PM- diphenhydramine citrate and ibuprofen tablet, coated 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • Active ingredients (in each caplet)

    Diphenhydramine citrate 38 mg

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    Nighttime sleep-aid

    Pain reliever

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  • Uses

    for relief of occasional sleeplessness when associated with minor aches and pains
    helps you fall asleep and stay asleep
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  • 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)

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  • 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
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  • 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)
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, glyceryl behenate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

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  • Questions or comments?

    1-877-932-7948

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  • Principal Display Panel

    compare to Motrin® PM active ingredients

    ibuprofen PM

    ibuprofen and diphenhydramine citrate tablets, 200mg/38 mg

    actual size

    pain reliever (NSAID)

    nighttime sleep-aid

    see new warnings information

    **capsule-shaped tablets

    Ibuprofen PM Carton Image 1
    Ibuprofen PM Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    EQUALINE IBUPROFEN PM 
    diphenhydramine citrate, ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-561
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    GLYCERYL DIBEHENATE  
    HYDROXYPROPYL CELLULOSE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code L413
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-561-60 1 in 1 CARTON
    1 20 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079113 01/11/2012
    Labeler - Supervalu Inc (006961411)
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