PAIN RELIEF PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]

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  • PAIN RELIEF PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]

PAIN RELIEF PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]
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NDC 69452-264-22
Set ID 58666a5c-fc92-4c8d-9c04-f0c98dc05c56
Category HUMAN OTC DRUG LABEL
Packager Bionpharma Inc.
Generic Name
Product Class
Product Number
Application Number ANDA090397
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  • Active ingredients (in each capsule)

    Diphenhydramine hydrochloride 25 mg

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    *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 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 children 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.

    ■ store at 20° to 25°C (68° to 77°F)

    ■ avoid excessive heat above 40°C (104°F)

    ■ 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 toll free 1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Bionpharma Inc.

    600 Alexander Road

    Princeton, NJ 08540

    †All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil® PM LIQUI-GELS®.

    DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

    R0319

    L0000084

  • Principal Display Panel

    †compare to the active ingredients in Advil® PM Liqui-Gels®

    NDC 69452-264-22

    a+health

    pain relief pm

    solubilized ibuprofen, 200 mg/diphenhydramine HCl, 25 mg

    pain reliever (NSAID)/nighttime sleep-aid

    120 capsules**

    **liquid-filled capsule

                                                                                                      FRONT

    120's Bottle Carton

                                                                                                     BACK

    120's Bottle Carton

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    ibuprofen, diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-264
    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
    ShapeOVALSize19mm
    FlavorImprint Code IBUPM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-264-22120 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09039705/01/2019
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-264)
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