Label: IBUPROFEN AND DIPHENHYDRAMINE HCL capsule, liquid filled

  • NDC Code(s): 64380-732-11, 64380-732-12, 64380-732-13, 64380-732-14, view more
    64380-732-15, 64380-732-18, 64380-732-19, 64380-732-20, 64380-732-29
  • Packager: Strides Shasun Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 5, 2018

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

  • 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

    • 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, or 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 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 medical overdose, get medical help or contact a Poison Control Center right away.

  • 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

  • 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.

  • QUESTIONS OR COMMENTS?

    Call at 1877 244 9825

    Manufactured by:

    Strides Shasun Limited

    Bengaluru - 562106, India

    Distributed by:

    Strides Pharma Inc.

    East Brunswick, NJ 08816

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    16 s label

    16 s label

    20 s count container label

    20 s count container label

    20 s count carton label

    20 s count carton label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE HCL 
    ibuprofen and diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64380-732
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    Product Characteristics
    ColorPURPLE (Bluish purple color) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 1007
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64380-732-142 in 1 CARTON03/05/2012
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:64380-732-154 in 1 CARTON03/05/2012
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:64380-732-2024 in 1 BOX03/05/2012
    3NDC:64380-732-1924 in 1 CARTON
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:64380-732-291 in 1 CARTON12/28/2016
    420 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:64380-732-121 in 1 CARTON12/28/2016
    540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:64380-732-131 in 1 CARTON12/28/2016
    680 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:64380-732-111 in 1 CARTON12/28/2016
    7120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:64380-732-181 in 1 CARTON12/28/2016
    8180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20088803/05/2012
    Labeler - Strides Shasun Limited (650738743)
    Registrant - Strides Shasun Limited (650738743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Shasun Limited918513263ANALYSIS(64380-732) , MANUFACTURE(64380-732)