IBUPROFEN AND DIPHENHYDRAMINE HCL (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.)]

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  • IBUPROFEN AND DIPHENHYDRAMINE HCL (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.)]

IBUPROFEN AND DIPHENHYDRAMINE HCL (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [EQUATE (WAL-MART STORES, INC.)]
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NDC 49035-065-40
Set ID 17e9f4aa-404e-45a1-adc9-e775c4ec36ec
Category HUMAN OTC DRUG LABEL
Packager EQUATE (Wal-Mart Stores, Inc.)
Generic Name
Product Class
Product Number
Application Number ANDA090397
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  • Active ingredient (in each capsule)

    Diphenhydramine hydrochloride 25 mg

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)
    (present as the free acid and potassium salt)
    *non-steroidal anti-inflammatory drug

  • Purpose

    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:

    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    Do not use

    • in children under 12 years of age
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
    • unless you have time for a full night’s sleep
    • with any other product containing diphenhydramine, even one used on skin
    • if you have sleeplessness without pain

    Ask a doctor before use if

    • the stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have glaucoma
    • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have a breathing problem such as emphysema or chronic bronchitis
    • 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
    • taking any other drug
    • taking any other antihistamines
    • taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
    • under a doctor's care for any continuing medical illness

    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
      • have bloody or black stools
      • vomit blood
      • have stomach pain that does not get better
    • pain gets worse or last 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.

  • Directions

    • do not take more than directed
    • adults and childlren 12 years and over:
      • take 2 capsules at bedtime
      • do not take more than 2 capsules in 24 hours
  • Other information

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • do not chew or crush prior to swallowing
    • protect from light
  • Inactive ingredients

    FD&C blue #1, FD&C red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

  • Questions or comments?

    Call 1-888-287-1915

  • Principal Display Panel

    Compare to Advil® PM Liqui-Gels® Active Ingredients**

    Ibuprofen PM Softgels

    Ibuprofen 200 mg

    Diphenhydramine HCl, 25 mg

    Pain Reliever (NSAID) / Nighttime Sleep-Aid

    NIGHTTIME

    SOFTGELS**

    (**liquid filled capsules)

    **This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DO NOT USE IF TAMPER-EVIDENT: SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

    DISTRIBUTED: BY Wal-Mart Stores, Inc.,

    Bentonville, AR 72716

  • Product Packaging

    Diphenhydramine Hydrochloride 25 mg, Solublized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

    Equate Ibuprofen PM Softgels

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE HCL 
    ibuprofen, diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-065
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code IBUPM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-065-401 in 1 BOX12/31/2015
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09039712/31/2015
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
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