Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 16, 2017

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

  • Purpose

    Pain reliever
    Nighttime sleep aid

  • Uses

    temporarily relieves 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 4000 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 sever 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
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist 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.

    • You may report side effects to 1-888-952-0050
  • If pregnant or breast-feeding,

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

  • Keep out of reach of children

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 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. Do not take more than 2 caplets of this product in 24 hours 

    children under 12 years: do not use

  • Inactive Ingredients

    croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Package/Label Principal Display Panel

    Health A2Z®                  Compare to Tylenol® PM active ingredient*

    See New Warnings Information

    Extra Strength

    Pain Reliever/Sleep Aid

    PAIN RELIEF PM  
    Acetaminophen 500mg   
    Diphenhydramine HCl 25mg

    Caplets

    Pain Relief PM 24ct. Caplets

    Pain Relief PM 24ct. Caplets

    Pain Relief PM 24ct. Caplets

    Pain Relief PM 24ct. Caplets

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM  EXTRA STRENGTH
    acetaminophen 500 mg and diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-267
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (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
    ShapeCAPSULESize16mm
    FlavorImprint Code AZ267
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-267-02150 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-267-2424 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    3NDC:69168-267-5050 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    4NDC:69168-267-99365 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/23/2014
    Labeler - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-267) , LABEL(69168-267) , MANUFACTURE(69168-267) , PACK(69168-267)
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