Label: ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 

  • NDC Code(s): 0573-0164-04, 0573-0164-05, 0573-0164-12, 0573-0164-14, view more
    0573-0164-20, 0573-0164-21, 0573-0164-30, 0573-0164-32, 0573-0164-33, 0573-0164-40, 0573-0164-41, 0573-0164-43, 0573-0164-44, 0573-0164-45, 0573-0164-55, 0573-0164-91
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 09/14

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

  • DRUG FACTS
  • 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.

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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

    calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

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  • QUESTIONS OR COMMENTS?

    Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

    For most recent product information, visit www.Advil.com.

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  • PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label

    Advil®PM

    Ibuprofen, 200 mg/Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID)/Nighttime Sleep-Aid

    20 Caplets

    Caplets

    READ AND KEEP CARTON FOR COMPLETE
    WARNINGS AND INFORMATION

    PRINCIPAL DISPLAY PANEL - 20 Caplet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

    Advil®PM

    Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID) / Nighttime Sleep-Aid

    20 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton
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  • PRINCIPAL DISPLAY PANEL - 4 Caplet Carton

    COUPON INSIDE

    for next purchase
    of 16ct or larger

    Advil®PM

    Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID) / Nighttime Sleep-Aid

    4 Coated Caplets*
    *Capsule-Shaped Tablets

    Caplets

    PRINCIPAL DISPLAY PANEL - 4 Caplet Carton
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  • PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch

    Advil®PM

    Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID)/Nighttime Sleep-Aid

    2 Caplets

    PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch
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  • PRINCIPAL DISPLAY PANEL - 50 Pouch Tray

    Advil®PM

    Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg
    Pain Reliever (NSAID) / Nighttime Sleep-Aid

    Caplets

    • For relief of occasional sleeplessness when
      associated with minor aches and pains
    • Helps you fall asleep and stay asleep

    50 PACKETS OF 2 COATED CAPLETS*
    *Capsule-Shaped Tablets

    PRINCIPAL DISPLAY PANEL - 50 Pouch Tray
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  • INGREDIENTS AND APPEARANCE
    ADVIL PM 
    diphenhydramine citrate and ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0573-0164
    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
    CALCIUM STEARATE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 2  
    GLYCERYL DIBEHENATE  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code Advil;PM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-0164-33 1 in 1 CARTON
    1 50 in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:0573-0164-04 4 in 1 POUCH; Combination Product Type = C112160
    3 NDC:0573-0164-20 1 in 1 CARTON
    3 20 in 1 BOTTLE; Combination Product Type = C112160
    4 NDC:0573-0164-30 1 in 1 CARTON
    4 40 in 1 BOTTLE; Combination Product Type = C112160
    5 NDC:0573-0164-40 1 in 1 CARTON
    5 80 in 1 BOTTLE; Combination Product Type = C112160
    6 NDC:0573-0164-43 1 in 1 CARTON
    6 120 in 1 BOTTLE; Combination Product Type = C112160
    7 NDC:0573-0164-45 1 in 1 CARTON
    7 180 in 1 BOTTLE; Combination Product Type = C112160
    8 NDC:0573-0164-32 1 in 1 CARTON
    8 50 in 1 BOTTLE; Combination Product Type = C112160
    9 NDC:0573-0164-41 1 in 1 CARTON
    9 100 in 1 BOTTLE; Combination Product Type = C112160
    10 NDC:0573-0164-91 3000 in 1 BOX
    10 2 in 1 POUCH; Combination Product Type = C112160
    11 NDC:0573-0164-05 2 in 1 CARTON
    11 2 in 1 BOTTLE; Combination Product Type = C112160
    12 NDC:0573-0164-55 50 in 1 TRAY
    12 2 in 1 POUCH; Combination Product Type = C112160
    13 NDC:0573-0164-21 1 in 1 CARTON
    13 30 in 1 BOTTLE; Combination Product Type = C112160
    14 NDC:0573-0164-44 1 in 1 CARTON
    14 140 in 1 BOTTLE; Combination Product Type = C112160
    15 NDC:0573-0164-14 2 in 1 CARTON
    15 2 in 1 POUCH; Combination Product Type = C112160
    16 NDC:0573-0164-12 6 in 1 CARTON
    16 2 in 1 POUCH; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021394 12/21/2005
    Labeler - Pfizer Consumer Healthcare (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    Wyeth Pharmaceuticals Company, Consumer Site 829390975 ANALYSIS(0573-0164), LABEL(0573-0164), MANUFACTURE(0573-0164), PACK(0573-0164)
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