Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 15, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each Caplet)Purpose
    Acetaminophen 500 mgPain reliever/ fever reducer
    Diphenhydramine HCL 25 mgSleep 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUEScoreno score
    ShapeOVAL (Capsule Shaped) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-041-311 in 1 DRUM
    131000 in 1 BAG
    2NDC:65437-041-501 in 1 DRUM
    250000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
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