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, 0573-0164-46, 0573-0164-49, 0573-0164-55, 0573-0164-91
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 01/15

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 - 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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  • PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton

    Advil®PM

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

    Caplets

    4 Coated Caplets*
    *Capsule-Shaped Tablets

    PRINCIPAL DISPLAY PANEL - 4 Caplet Pouch Carton
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  • INGREDIENTS AND APPEARANCE
    ADVIL PM 
    diphenhydramine citrate and ibuprofen tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0164
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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; Type 0: Not a Combination Product
    2 NDC:0573-0164-04 4 in 1 POUCH; Type 0: Not a Combination Product
    3 NDC:0573-0164-20 1 in 1 CARTON
    3 20 in 1 BOTTLE; Type 0: Not a Combination Product
    4 NDC:0573-0164-30 1 in 1 CARTON
    4 40 in 1 BOTTLE; Type 0: Not a Combination Product
    5 NDC:0573-0164-40 1 in 1 CARTON
    5 80 in 1 BOTTLE; Type 0: Not a Combination Product
    6 NDC:0573-0164-43 1 in 1 CARTON
    6 120 in 1 BOTTLE; Type 0: Not a Combination Product
    7 NDC:0573-0164-45 1 in 1 CARTON
    7 180 in 1 BOTTLE; Type 0: Not a Combination Product
    8 NDC:0573-0164-32 1 in 1 CARTON
    8 50 in 1 BOTTLE; Type 0: Not a Combination Product
    9 NDC:0573-0164-41 1 in 1 CARTON
    9 100 in 1 BOTTLE; Type 0: Not a Combination Product
    10 NDC:0573-0164-91 3000 in 1 BOX
    10 2 in 1 POUCH; Type 0: Not a Combination Product
    11 NDC:0573-0164-05 2 in 1 CARTON
    11 2 in 1 BOTTLE; Type 0: Not a Combination Product
    12 NDC:0573-0164-55 50 in 1 TRAY
    12 2 in 1 POUCH; Type 0: Not a Combination Product
    13 NDC:0573-0164-21 1 in 1 CARTON
    13 30 in 1 BOTTLE; Type 0: Not a Combination Product
    14 NDC:0573-0164-44 1 in 1 CARTON
    14 140 in 1 BOTTLE; Type 0: Not a Combination Product
    15 NDC:0573-0164-14 2 in 1 CARTON
    15 2 in 1 POUCH; Type 0: Not a Combination Product
    16 NDC:0573-0164-12 6 in 1 CARTON
    16 2 in 1 POUCH; Type 0: Not a Combination Product
    17 NDC:0573-0164-49 1 in 1 CARTON
    17 200 in 1 BOTTLE; Type 0: Not a Combination Product
    18 NDC:0573-0164-46 1 in 1 CARTON
    18 180 in 1 BOTTLE; Type 0: Not a Combination Product
    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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