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

  • NDC Code(s): 0573-0164-04, 0573-0164-05, 0573-0164-08, 0573-0164-09, view more
    0573-0164-12, 0573-0164-14, 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, 0573-0164-65, 0573-0164-91
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 2, 2021

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

  • Purposes

    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

    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

    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

    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, asthma, or had a stroke
    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

    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
    you have symptoms of heart problems or stroke:
    chest pain
    trouble breathing
    weakness in one part or side of body
    slurred speech
    leg swelling
    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 at 20 weeks or later in 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 caplets at bedtime
    do not take more than 2 caplets in 24 hours
  • Other ingredients

    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)
  • Inactive ingredients

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

  • Questions or Comments?

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

  • Additional Information

    Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

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

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    ©2021 GSK or licensor Trademarks owned or licensed by GSK

  • Principal Display Panel

    NDC 0573-0164-20

    Advil PM

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

    20
    Coated Caplets*
    *Capsule-Shaped Tablets

    Advil PM 20 Coated Caplets
  • INGREDIENTS AND APPEARANCE
    ADVIL PM 
    diphenhydramine citrate and ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0164
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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
    ColorBLUE (blue) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code Advil;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0164-331 in 1 CARTON12/21/2005
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0573-0164-044 in 1 POUCH; Type 0: Not a Combination Product12/21/2005
    3NDC:0573-0164-201 in 1 CARTON12/21/2005
    320 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0573-0164-301 in 1 CARTON12/21/2005
    440 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0573-0164-401 in 1 CARTON12/21/2005
    580 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0573-0164-431 in 1 CARTON12/21/2005
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0573-0164-451 in 1 CARTON12/21/2005
    7180 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0573-0164-321 in 1 CARTON12/21/2005
    850 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0573-0164-411 in 1 CARTON12/21/2005
    9100 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0573-0164-913000 in 1 BOX12/21/2005
    102 in 1 POUCH; Type 0: Not a Combination Product
    11NDC:0573-0164-052 in 1 CARTON12/21/2005
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:0573-0164-5550 in 1 TRAY12/21/2005
    122 in 1 POUCH; Type 0: Not a Combination Product
    13NDC:0573-0164-211 in 1 CARTON12/21/2005
    1330 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:0573-0164-441 in 1 CARTON12/21/2005
    14140 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:0573-0164-142 in 1 CARTON12/21/2005
    152 in 1 POUCH; Type 0: Not a Combination Product
    16NDC:0573-0164-126 in 1 CARTON12/21/2005
    162 in 1 POUCH; Type 0: Not a Combination Product
    17NDC:0573-0164-491 in 1 CARTON12/21/2005
    17200 in 1 BOTTLE; Type 0: Not a Combination Product
    18NDC:0573-0164-461 in 1 CARTON12/21/2005
    18180 in 1 BOTTLE; Type 0: Not a Combination Product
    19NDC:0573-0164-65120 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2016
    20NDC:0573-0164-081 in 1 PACKAGE03/17/2017
    208 in 1 VIAL; Type 0: Not a Combination Product
    21NDC:0573-0164-098 in 1 VIAL; Type 0: Not a Combination Product03/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02139412/21/2005
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-0164) , LABEL(0573-0164) , MANUFACTURE(0573-0164) , PACK(0573-0164)