Label: PAIN RELIEF PM- acetaminophen, diphenhydramine tablet

  • NDC Code(s): 72090-006-25
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

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

  • Active Ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine 25 mg

  • Purpose

    Acetaminophen 500 mg ....................................................................................................................................Pain reliever
    Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid

  • Uses:

    • temporary 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 ■ more than 4,000 mg of acetaminophen in 24 hrs ■ 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 ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away.

  • 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 have ever had an allergic reaction to this product or any of its ingredients.

  • Ask a doctor before use if you have:

    ■ liver disease

    ■ glaucoma

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ trouble urinating due to an enlarged prostate gland.

  • Ask a doctor or pharmacist before use if you are 

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers
  • When using this product

    ■ drowsiness will occur

    ■ avoid alcoholic drinks

    ■ do not drive a motor vehicle or operate machinery.

  • Stop use and ask a doctor if

    ■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    ■ pain gets worse or lasts more than 10 days

    ■ fever gets worse or lasts more than 3 days

    ■ redness or swelling is present

    ■ new symptoms occur. 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

    KEEP OUT OF REACH OF CHILDREN

    Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) 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
    ■ take 2 caplets at bedtime

    ■ do not take more than 2 caplets in 24 hours unless directed by a doctor

    ■ children under 12 years do not use

  • Other Information:

    • store at 20°-25°C (68°-77°F)
    • do not use if foil or inner seal is broken or missing

  • Inactive Ingredients:

    FD & C Blue # 1, FD & C Blue # 2, Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene glycol 400, Pregelatinized Starch, Polyvinyl Pyrrolidone, Stearic Acid Powder, Titanium Dioxide.

  • Questions or Comments?

    Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare
    Division., owner of the registered trademark Tylenol® Extra Strength Tablets.

    Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANEL

    PL0035-Rev 01 Pain Relief PM- 375ct - Elysium 08.02.2023_page-0001

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM 
    acetaminophen, diphenhydramine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-006
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Magnesium Stearate (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize27mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-006-25375 in 1 BOTTLE; Type 0: Not a Combination Product05/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/08/2024
    Labeler - Pioneer Life Sciences, LLC (014092742)
    Registrant - Pioneer Life Sciences, LLC (014092742)