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ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE (Cispharma, Inc)

Available Formats

Dosage Form Package Information Links
TABLET 24390 TABLET in 1 DRUM (52204-124-99) Label Information

Complete ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Information

  • Drug Facts

    Active ingredient (in each caplet)

    Acetaminophen ..............................500 mg

    Diphenhydramine HCl ......................25 mg


  • PURPOSE

    Pain Reliver

    Nighttime Sleep Aid


  • Uses

    temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness


  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take; â–  more than 4,000 mg of acetaminophen in 24 hours; â–  with other drugs containing acetaminophen; â–  3 or more alcoholic drinks everyday while using this product

    Do not use

    â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. â–  with any product containing diphenhydramine, even one used on skin â–  in children under 12 years of age â–  if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    â–  liver disease; â–  a breathing problem such as emphysema or chronic bronchitis; â–  trouble urinating due to an enlarged prostate gland; â–  glaucoma

    Ask a doctor or pharmacist before use if you are

    â–  taking the blood thinning drug warfarin; â–  taking sedatives or tranquilizers

    When using this productâ–  drowsiness will occur â–  avoid alcoholic drinks â–  do not drive a motor vehicle or operate machinery.

    Stop use and ask a doctor if

    â–  sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. â–  pain gets worse or lasts more than 10 days

    â–  fever gets worse or lasts more than 3 days â–  redness or swelling is present

    â–  new symptoms occur

    These could be signs of a serious condition.

    Indicated for pain relief and night time sleep aid.

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

    Keep out of reach of children.


  • Overdasage Warnings;

    Taking more than the recommended dose (overdose) may liver damage. In case of overdose, get medical help or contact poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


  • Directions: do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • 2 caplets at bedtime
    • do not take more than 2 caplets of this product in 24 hours

    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 may cause liver damage.

  • Other Information

    • store between 20°- 25°C (68°- 77°F)
    • do not use if the box is opened

  • Inactive Ingredients

    Carnauba wax, FD&C blue # 1 al lake, FD&C blue # 2 al lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin


  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® PM

    Questions or Comments?
    Call 1-866-383-9908

    Manufactured by:

    Cispharma Inc
    1212 Cranbury S River Road
    Cranbury, NJ 08512


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52204-124
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color BLUE (Blue) Score no score
    Shape CAPSULE (CAPSULE) Size 18mm
    Flavor Imprint Code C;24
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52204-124-99 24390 in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/28/2011
    Labeler - Cispharma, Inc (833171445)
    Registrant - Cispharma, Inc (833171445)
    Establishment
    Name Address ID/FEI Business Operations
    Cispharma, Inc 833171445 manufacture