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Ibuprofen and Diphenhydramine Citrate (Dr. Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 CARTON (55111-565-05) > 500 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-30) > 30 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-14) > 20 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-40) > 40 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-80) > 80 TABLET in 1 BOTTLE Label Information
TABLET 2500 TABLET in 1 POUCH (55111-565-92) Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-18) > 180 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-565-90) > 90 TABLET in 1 BOTTLE Label Information

Complete Ibuprofen and Diphenhydramine Citrate Information

  • DRUG FACTS


  • ACTIVE INGREDIENTS (IN EACH CAPLET*)

    Diphenhydramine citrate USP, 38 mg

    Ibuprofen USP, 200 mg (NSAID)**

    * capsule-shaped tablets

    **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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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

    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 you have
    • a breathing problem such as emphysema or chronic bronchitis
    • problems or serious side effects from taking pain relievers or fever reducers
    • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
    • ulcers
    • bleeding problems
    • high blood pressure
    • heart or kidney disease
    • asthma
    • taken a diuretic
    • reached age 60 or older
    • glaucoma
    • 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 containing an NSAID (prescription or nonprescription)
    • under a doctor’s care for any continuing medical illness
    • taking any other antihistamines
    • taking a blood thinning (anticoagulant) or steroid drug
    • 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
    • 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
    • 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.
    • stomach pain or upset gets worse or lasts
    • 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 the 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
    • do not take longer than 10 days, unless directed by a doctor (see WARNINGS)
    • adults and children 12 years and over: take 2 caplets at bedtime.
    • do not take more than 2 caplets in 24 hours

  • OTHER INFORMATION

    • 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)

  • INACTIVE INGREDIENTS

    carnauba wax, corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2, hypromelllose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, pregelatinized starch, sodium lauryl sulfate, stearic acid, titanium dioxide


  • QUESTIONS OR COMMENTS?

    Call 1-888-375-3784


  • SPL UNCLASSIFIED SECTION

    Do Not Use if foil seal under bottle cap imprinted with“SEALED for YOUR PROTECTION”  is broken or missing.

    Manufactured for:Dr. Reddy’s Laboratories Limited Bachepalli – 502 325 INDIA.


  • PRINCIPAL DISPLAY PANEL

    Pouch label:

    DR. REDDY'S

    NDC 55111-565-92

    Count :2,500 Tablets

    Ibuprofen Diphenhydramine Citrate Tablets 200 mg/38 mg

    Batch No. :

    Mfg. Date :

    Repack Before :

    Expiration Date :

    Store at 20°-25°C (68°-77°F)

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

    For Repackaging only.

    DO NOT OPEN POUCHES UNTIL REPACKAGING

    Mfd. by : Dr. Reddy's Laboratories Limited

    Bachepalli - 502 325 INDIA.

    Container:

    container

    Carton:

    carton

    Pouch Label:

    pouchlabel


  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE CITRATE 
    ibuprofen and diphenhydramine citrate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-565
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ibuprofen (UNII: WK2XYI10QM) (ibuprofen - UNII:WK2XYI10QM) ibuprofen 200 mg
    diphenhydramine citrate (UNII: 4OD433S209) (diphenhydramine - UNII:8GTS82S83M) diphenhydramine 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    carnauba wax (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    colloidal silicon dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    polydextrose (UNII: VH2XOU12IE)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    stearic acid (UNII: 4ELV7Z65AP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE (blue) Score no score
    Shape CAPSULE (slightly glossy smooth blue film coated) Size 15mm
    Flavor Imprint Code RDY;565
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-565-14 1 in 1 CARTON
    1 20 in 1 BOTTLE
    2 NDC:55111-565-30 1 in 1 CARTON
    2 30 in 1 BOTTLE
    3 NDC:55111-565-40 1 in 1 CARTON
    3 40 in 1 BOTTLE
    4 NDC:55111-565-80 1 in 1 CARTON
    4 80 in 1 BOTTLE
    5 NDC:55111-565-90 1 in 1 CARTON
    5 90 in 1 BOTTLE
    6 NDC:55111-565-18 1 in 1 CARTON
    6 180 in 1 BOTTLE
    7 NDC:55111-565-05 1 in 1 CARTON
    7 500 in 1 BOTTLE
    8 NDC:55111-565-92 2500 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090619 01/31/2010
    Labeler - Dr. Reddy's Laboratories Limited (862179079)