Label: IBUPROFEN AND DIPHENHYDRAMINE CITRATE tablet, coated

  • NDC Code(s): 58602-867-09, 58602-867-12, 58602-867-14, 58602-867-18, view more
    58602-867-21, 58602-867-23, 58602-867-27, 58602-867-32, 58602-867-34, 58602-867-46, 58602-867-70, 58602-867-72, 58602-867-73, 58602-867-78, 58602-867-80, 58602-867-92, 58602-867-97
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 3, 2022

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

  • Drug Facts

    Active ingredients
    (in each caplet)

    Diphenhydramine citrate USP 38 mg
    Ibuprofen USP 200 mg (NSAID)*
    *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 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, 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 a 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 at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over: take 2 capsules at bedtime
    • do not take more than 2 capsules in 24 hours

    Other information

    • read all warnings and directions before use. Keep carton.
    • store at 20° to 25°C (68° to 77°F)
    • avoid excessive heat above 40°C (104°F)

  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and titanium dioxide.

    Questions or comments?

    Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road,
    East Windsor NJ 08520

    Made in India

    Code No.: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Label

    AUROHEALTH
    NDC 58602-867-73
    Ibuprofen and
    Diphenhydramine Citrate
    Tablets
    200 mg/38 mg
    Pain Reliever (NSAID)/Nighttime Sleep-Aid
    20
    Coated Caplets*                  *Capsule-Shaped Tablets



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Label



  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Carton Label

    AUROHEALTH
    NDC 58602-867-73
    Compare to the active
    ingredients in Advil® PM
    Ibuprofen and
    Diphenhydramine Citrate
    Tablets
    200 mg/38 mg
    Pain Reliever (NSAID)/
    Nighttime Sleep-Aid
    20
    Coated Caplets*
    *Capsule-Shaped Tablets            200 
                                                          Actual size   

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg/38 mg (20 Coated Caplets) Bottle Carton Label

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN AND DIPHENHYDRAMINE CITRATE 
    ibuprofen and diphenhydramine citrate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-867
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code DI;200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-867-731 in 1 CARTON05/31/2022
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-867-091 in 1 CARTON05/31/2022
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-867-121 in 1 CARTON05/31/2022
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:58602-867-141 in 1 CARTON05/31/2022
    450 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-867-181 in 1 CARTON05/31/2022
    580 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-867-211 in 1 CARTON05/31/2022
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-867-231 in 1 CARTON05/31/2022
    7120 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-867-27140 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2022
    9NDC:58602-867-32180 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2022
    10NDC:58602-867-34200 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2022
    11NDC:58602-867-701 in 1 CARTON05/31/2022
    1140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    12NDC:58602-867-781 in 1 CARTON05/31/2022
    1250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    13NDC:58602-867-721 in 1 CARTON05/31/2022
    1380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    14NDC:58602-867-97120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2022
    15NDC:58602-867-46140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2022
    16NDC:58602-867-92180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2022
    17NDC:58602-867-80200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21620405/31/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-867) , MANUFACTURE(58602-867)