Label: IBUPROFEN AND DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride and ibuprofen capsule, liquid filled

  • NDC Code(s): 64380-732-14, 64380-732-15, 64380-732-19, 64380-732-20
  • Packager: Strides Arcolab Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • ACTIVE INGREDIENT

    Active Ingredient(s)                                                                  

    (In each capsule)

    Diphenhydramine hydrochloride 25 mg

    Solubilized Ibuprofen equal to Ibuprofen 200 mg (NSAID)* (Present as the free acid and potassium salt)

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    • Nighttime sleep-aid
    • Pain reliever
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  • USES

    • For relief of occasional sleeplessness when associated with minor aches and pains
    • Helps you fall asleep and stay asleep
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  • 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
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  • 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
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  • ASK 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, or asthma
    • 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
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  • ASK DOCTOR/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
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  • 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
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  • 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

    •    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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    In case of medical overdose, get medical help or contact a Poison Control Center right away.

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  • DIRECTIONS

    1. do not take more than directed
    2. adults and children 12 years and over: take 2 capsules at bedtime
    3. 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 20-25°C (68-77°F)

    • Avoid excessive heat above 40°C (104°F)

    • Protect from light

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  • INACTIVE INGREDIENT

    Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.

    Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.

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  • QUESTIONS OR COMMENTS?

    Call at 1877 244 9825

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    16s label

    16s label

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  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE HCL 
    ibuprofen and diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64380-732
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE 25 mg
    IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    FD&C BLUE NO. 1  
    GELATIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    POTASSIUM HYDROXIDE  
    WATER  
    SORBITAN  
    SORBITOL  
    SHELLAC  
    TITANIUM DIOXIDE  
    BUTYL ALCOHOL  
    LECITHIN, SOYBEAN  
    POLYETHYLENE GLYCOL 600  
    Product Characteristics
    Color PURPLE (Bluish purple color) Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code 1007
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64380-732-20 24 in 1 BOX
    1 NDC:64380-732-19 24 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:64380-732-14 2 in 1 CARTON
    2 8 in 1 BLISTER PACK
    3 NDC:64380-732-15 4 in 1 CARTON
    3 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200888 03/05/2012
    Labeler - Strides Arcolab Limited (650738743)
    Registrant - Strides Arcolab Limited (650738743)
    Establishment
    Name Address ID/FEI Business Operations
    Strides Arcolab Limited 918513263 Analysis(64380-732), Manufacture(64380-732)
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