Home > Drugs A-Z > Ibuprofen and Diphenhydramine HCl

Ibuprofen and Diphenhydramine HCl (Premier Value (Chain Drug Consortium, LLC))

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 BOX (68016-217-16) > 16 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information
CAPSULE, LIQUID FILLED 1 BOTTLE in 1 BOX (68016-217-32) > 32 CAPSULE, LIQUID FILLED in 1 BOTTLE Label Information

Complete Ibuprofen and Diphenhydramine HCl Information

  • 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:

    • 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 decrease 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 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. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • 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 1-877-753-3935 Monday-Friday 9AM to 5PM EST


  • Principal Display Panel

    †COMPARE TO THE ACTIVE INGREDIENTS IN ADVIL® PM LIQUI-GELS®

    Ibuprofen PM Softgels

    PAIN RELIEVER (NSAID)/NIGHTTIME SLEEP-AID

    Solubilized Ibuprofen, 200 mg

    Diphenhydramine HCl, 25 mg

    Softgels** (**Liquid Filled Capsules)

    †This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM Liqui-Gels®.

    DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC

    3301 N.W. BOCA RATON BLVD., SUITE 101

    BOCA RATON, FL  33431

    Rev# 09/12

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.



  • Product Packaging

    Diphenhydramine 25 mg, Ibuprofen 200 mg

    Premier Value Ibuprofen PM Softgels


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE HCL 
    ibuprofen, diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-217
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color BLUE (BLUE) Score no score
    Shape OVAL (OVAL) Size 19mm
    Flavor Imprint Code IBUPM
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-217-16 1 in 1 BOX
    1 16 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:68016-217-32 1 in 1 BOX
    2 32 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090397 01/04/2013
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - P & L Development, LLC (800014821)