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Pill Identifier Information of Motrin PM (diphenhydramine citrate 38 MG / ibuprofen 200 MG) Oral Tablet

Drug Information

Motrin PM (diphenhydramine citrate 38 MG / ibuprofen 200 MG) Oral Tablet

Imprint: MOTRIN;PM
Shape: C48345
Color: C48325
Ingredients: Diphenhydramine; Ibuprofen
Size: 15.00
Score: 1
Rxtty: SY
Author: McNeil Consumer Healthcare Div McNeil-PPC, Inc
Inactive Ingredients: >

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Diphenhydramine citrate 38 mgNighttime sleep-aid
    Ibuprofen 200 mg (NSAID) *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

    When using this product

    Stop use and ask a doctor if

  • you have symptoms of heart problems or stroke:
  • 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. (1-800-222-1222)

  • Directions

  • Other information

  • 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

  • Questions or comments?

    call 1-800-962-5357 (toll-free) or 215-273-8755 (collect)

  • OTHER SAFETY INFORMATION

    Do not use if foil inner seal printed “SEALED for YOUR PROTECTION” is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    See Revised Warning

    NDC 50580-563-80

    Motrin ® PM

    Ibuprofen, 200 mg /

    Diphenhydramine citrate, 38 mg Tablets

    Pain Reliever (NSAID)/Nighttime Sleep-Aid

    80 Coated Caplets**

    **Capsule-Shaped Tablets

    Actual Size

    CAPLETS**

    motrin-01

  • INGREDIENTS AND APPEARANCE
    MOTRIN  PM
    ibuprofen and diphenhydramine citrate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-563
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code MOTRIN;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-563-201 in 1 CARTON01/11/2010
    120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:50580-563-401 in 1 CARTON01/11/201001/31/2019
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:50580-563-801 in 1 CARTON01/11/2010
    380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911301/11/2010
    Labeler - Kenvue Brands LLC (118772437)