Home > Pill Identifier > Diphenhydramine Citrate 38 MG / Ibuprofen 200 MG Oral Tablet

Pill Identifier Information of Diphenhydramine Citrate 38 MG / Ibuprofen 200 MG Oral Tablet

Drug Information

Diphenhydramine Citrate 38 MG / Ibuprofen 200 MG Oral Tablet

Imprint: RDY;565
Shape: C48336
Color: C48333
Ingredients: Diphenhydramine; Ibuprofen
Size: 15.00
Score: 1
Rxtty: SCD
Author: Dr. Reddy's Laboratories Limited
Inactive Ingredients: carnauba wax / STARCH, CORN / colloidal silicon dioxide / croscarmellose sodium / FD&C blue no. 2 / CELLULOSE, MICROCRYSTALLINE / HYPROMELLOSE / polydextrose / polyethylene glycol 400 / sodium lauryl sulfate / stearic acid / titanium dioxide

Complete 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 an 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
    • 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

    Ask a doctor or pharmacist before use if you are

    When using this product

    Stop use and ask a doctor if

    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

  • OTHER INFORMATION

  • 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?

    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 by:

    Dr. Reddy’s Laboratories Limited

    Bachepalli – 502 325 INDIA.

  • PRINCIPAL DISPLAY PANEL

    Container:

    container

  • PRINCIPAL DISPLAY PANEL

    Container carton

    carton

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE CITRATE 
    ibuprofen and diphenhydramine citrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-565
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen200 mg
    Diphenhydramine Citrate (UNII: 4OD433S209) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Citrate38 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    hypromelloses (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
    ColorBLUE (blue) Scoreno score
    ShapeCAPSULE (slightly glossy smooth blue film coated) Size15mm
    FlavorImprint Code RDY;565
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-565-141 in 1 CARTON01/31/2010
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-565-301 in 1 CARTON01/31/2010
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-565-401 in 1 CARTON01/31/2010
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-565-801 in 1 CARTON01/31/2010
    480 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-565-901 in 1 CARTON01/31/2010
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-565-181 in 1 CARTON01/31/2010
    6180 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-565-051 in 1 CARTON01/31/2010
    7500 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-565-922500 in 1 POUCH; Type 0: Not a Combination Product01/31/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09061901/31/2010
    Labeler - Dr. Reddy's Laboratories Limited (650562841)