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

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

    Close
  • PURPOSE

    • Nighttime sleep-aid
    • Pain reliever
    Close
  • USES

    • For relief of occasional sleeplessness when associated with minor aches and pains
    • Helps you fall asleep and stay asleep
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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

    Close
  • 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.

    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    Close
  • 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

    Close
  • 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.

    Close
  • QUESTIONS OR COMMENTS?

    Call at 1877 244 9825

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    16s label

    16s label

    Close
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE HCL 
    ibuprofen and diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64380-732
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 25 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    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)
    Close