Label: NOTTS - PAIN RELIEF PM- acetaminophen, diphenhydramine hydrochloride tablet

  • NDC Code(s): 82706-009-01, 82706-009-02
  • Packager: VIVUNT PHARMA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain Reliever
    Diphenhydramine HCl 25 mgNighttime Sleep Aid
  • Uses

    Temporary relief of occasional headaches, minor aches and pains with accompanying sleeplessness

  • Warnings

    Liver Warning

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

    • more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • rash
    • blisters

    If a skin reaction occurs, stop use and seek medical attention immediately.

    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
    • if you are allergic to any other ingredient in this product.

    Ask a doctor before use if you have

    • liver disease
    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urinatation due to enlargement of the prostate gland

    When using this product

    avoid alcoholic drinks

    Ask a doctor or pharmacist before use if you are taking

    • the blood thinning drug warfarin
    • sedatives or tranquilizers

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
    • pain lasts more than 10 days
    • pain gets worse
    • new symptoms occur
    • redness or swelling is present.

    These could 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

    Do not take more the recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. Prompt 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
    • take 2 caplets at bedtime if needed, or as directed by a doctor.
    • do not take more than 2 caplets in 24 hours
    children under 12 yearsdo not use
  • Other information

    • Store between 20-25°C (68-77°F)
    • Tamper-evident: Do not use if carton is open or if the foil inner seal is broken or missing.
  • Inactive ingredients

    Corn Starch, FD&C Blue No. 2, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Stearic Acid, Sodium Starch Glycolate, Titanium Dioxide.

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Tylenol ® Extra Strength PM.

    Product of China

    Distributed by:

    VIVUNT PHARMA LLC

    8950 SW 74th Court, Suite 1901

    Miami, Florida Z.C. 33156-3175

  • PRINCIPAL DISPLAY PANEL - 24 Caplets

    NOTTS™

    Pain Relief PM

    Acetaminophen,

    Diphenhydramine HCl

    ​500 mg/ 25 mg each caplet

    Pain Reliever
    Nighttime Sleep Aid
    Non-habit Forming

    Compare to Tylenol® Extra Strength PM active ingredients*

    NDC 82706-009-01

    24 CAPLETS

    Box Notts Pain Relief PM x 24 caplets - 01

  • PRINCIPAL DISPLAY PANEL - 50 Caplets

    NOTTS™

    Pain Relief PM

    Acetaminophen,

    Diphenhydramine HCl

    500 mg/ 25 mg each caplet

    • Pain Reliever
    • Nighttime Sleep Aid
    • Non-habit Forming


    Compare to Tylenol® Extra Strength PM active ingredients*

    NDC 82706-009-02

    50 CAPLETS

    Box Notts Pain Relief PM x 24 caplets - 02

  • INGREDIENTS AND APPEARANCE
    NOTTS - PAIN RELIEF PM 
    acetaminophen, diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-009
    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. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code NOTTS;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-009-011 in 1 CARTON08/17/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:82706-009-021 in 1 CARTON08/17/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/17/2022
    Labeler - VIVUNT PHARMA LLC (045829437)