Label: EXTRA STRENGTH NIGHT TIME PAIN MEDICINE- acetaminophen, diphenhydramine hcl tablet

  • NDC Code(s): 57896-224-01, 57896-224-05
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 26, 2018

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

  • Active Ingredients

    Acetaminophen 500 mg

    Diphenhydramine HCI 25 mg

  • Purposes

    Pain Reliever

    Sleep aid

  • Uses

    for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than directed • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product

    Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

    • sedatives or tranquilizers

    When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

    Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.

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


    Keep out of reach of children.

    Overdose warning:
    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults / children even if you do not notice any signs / symptoms.

  • Directions

    • do not exceed recommended dose


    Adults and Children 12 years and over
    Take 2 caplets at bedtime if needed, or as directed by a doctor.
    Children under 12 years
    Do not use.

  • Other information

    • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

    • store at room temperature

  • Inactive ingredients

    cellulose, croscarmellose sodium, FD and C blue no.1, hypromellose, PEG, stearic acid, titanium dioxide. May also contain silica, sodium starch glycolate.

  • package Label

    57896-224-05

    Health star the sensible choice for price and health

    Extra Strength

    pain relief and sleep aid

    night time pain medicine

    acetaminophen 500 mg

    Diphenhydramine HCl 25mg

    100 caplets

    compare to the active ingredients in tylenol pm


    ES Night Time Pain Medicine label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NIGHT TIME PAIN MEDICINE 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-224
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULE (caplet) Size18mm
    FlavorImprint Code AZ267
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-224-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    2NDC:57896-224-0550 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1996
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(57896-224)