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

  • NDC Code(s): 69168-393-02, 69168-393-24, 69168-393-26, 69168-393-50, view more
    69168-393-99
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2018

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

  • Purpose

    Pain reliever
    Nighttime sleep aid

  • Uses

    temporarily 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 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 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
    • 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,

    ask a health professional before use.

  • 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
    May contain: carnauba wax, FD&C blue #2 aluminum lake, polysorbate 80

  • Package/Label Principal Display Panel

    Pain Relief Label

    Pain Relief Label

    Pain Relief

    Pain Relief

  • 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:69168-393
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code G651
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-393-02150 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-393-241 in 1 CARTON12/23/2014
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69168-393-501 in 1 CARTON12/23/2014
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69168-393-99365 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    5NDC:69168-393-261 in 1 CARTON12/15/2021
    520 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/23/2014
    Labeler - Allegiant Health (079501930)
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