Home > Drugs A-Z > ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (HIMPRIT PHARMACHEM PVT LTD)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-041-50) > 50000 TABLET, FILM COATED in 1 BAG Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (65437-041-31) > 31000 TABLET, FILM COATED in 1 BAG Label Information

Complete ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each Caplet) Purpose
    Acetaminophen 500 mg Pain reliever/ fever reducer
    Diphenhydramine HCL 25 mg Sleep Aid

  • Uses

    Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness


  • Warnings

    Alcohol Warnings

    If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

    Do not use
    *
    • with any other product containing acetaminophen
    *
    • with any other product containing diphenhydramine, even one used on skin
    *
    • in children under 12 years of age

    Ask a doctor before use if you have

    *
    • a breathing problem such as emphysema or chronic bronchitis
    *
    • glaucoma
    *
    • difficulty in urination due to enlargement of the prostate gland

    ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers

    When using this product

    *
    • do not exceed recommended dosage
    *
    • avoid alcoholic beverages
    *
    • marked drowsiness may occur
    *
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    *
    • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness
    *
    • new symptoms occur
    *
    • redness or swelling is present
    *
    • pain gets worse or lasts more than 10 days
    *
    • fever gets worse or lasts more than 3 days

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children. In case of accidental overdose get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Direction

    *
    • use as directed
    *
    • adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor
    *
    • Children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

  • Other information

    *
    • Store at room temperature

  • Inactive ingredients

    croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1


  • PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label

    ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
    Each Film coated Tablet Contains:

    ACETAMEINOPHEN 500 mg
    DIPHENHYDRAMINE HCL 25 mg

    Lot No :
    MFG. DATE :
    Exp. Date :
    Jar No. :
    Quantity : 31000 Tablets
    NDC. No : 65437-041-31

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

    MANUFACTURED BY:
    MANUFACTURED CODE No Guj/Drugs/G/1362
    LABELER CODE # 14803

    MANUFACTURED FOR:
    HIMPRIT PHARMACHEM PVT. LTD

    "LAKULISH", R.V.DESAI ROAD,
    NEXT TO NAVAPURA POLICE STATION
    BARODA, INDIA – 390 001

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    PRINCIPAL DISPLAY PANEL 500/25 mg Shipper Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-041
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL (Capsule Shaped) Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65437-041-31 1 in 1 DRUM
    1 31000 in 1 BAG
    2 NDC:65437-041-50 1 in 1 DRUM
    2 50000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 07/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)