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

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  • Purposes

    Pain Reliever

    Sleep aid

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  • Uses

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

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  • 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.

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  • 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.

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  • Other information

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

    • store at room temperature

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  • Inactive ingredients

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NIGHT TIME PAIN MEDICINE 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-224
    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
    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
    Color blue Score no score
    Shape CAPSULE (caplet) Size 18mm
    Flavor Imprint Code AZ267
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-224-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2012
    2 NDC:57896-224-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1996
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Allegiant Health 079501930 manufacture(57896-224)
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