Label: PAIN RELIEVER AND SLEEP AID- acetaminophen, and diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 68210-4236-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

  • Active Ingredient (in each tablet)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

  • Purpose

    Pain reliever
    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 hours • 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 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 • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma

  • Ask a doctor or pharmacist before use if you are 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 a serious underlying medical illness • pain gets worse or lasts for 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.

  • Overdose warning:

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 & children 12 years & over• take 2 tablets at bedtime
    • do not take more than 2 tablets of this product in 24 hours
    children under 12 yearsdo not use

  • Other information

    • store between 20–25°C (68–77°F)

  • Inactive ingredients

    FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • Distributed by:

    Cabinet Health P.B.C.

  • Principal Display Panel

    Pain Reliever PM SleepAid Pouch Front

    Pain Reliever PM SleepAid Pouch Back

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER AND SLEEP AID 
    acetaminophen, and diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4236
    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)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code S26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4236-1120 in 1 POUCH; Type 0: Not a Combination Product11/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/17/2022
    Labeler - Spirit Pharmaceuticals LLC (179621011)