Label: ACETAMINOPHEN DIPHENHYDRAMINE HCL capsule

  • 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 July 17, 2017

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

  • Active ingredient

    Active ingredient Purpose
    (in each gelcap)
    Acetaminophen, USP 500 mg
    Diphenhydramine HCl 25 mg

  • Purposes

    Pain reliever
    Nighttime sleep aid

  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • 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 reaction. 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 before use if you are

    ■ taking the blood thinning drug warfarin
    ■ taking sedatives or tranquilizers

  • When using this product

    ■ taking the blood thinning drug warfarin
    ■ taking sedatives or tranquilizers

  • 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.

  • 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 the reach of children.

  • Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. 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 and children 12 years and over
    ■ take 2 gelcaps at bedtime
    ■ do not take more than 2 gelcaps of this product in 24 hours
    children under 12 years
    do not use

  • Other information

    ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
    ■ see end panel for lot number and expiration date

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • EXTRA STRENGTH PAIN RELIEF PM Pain Reliever/Nighttime Sleep Aid Acetaminophen, USP 500 mg each/ Diphenhydramine HCl 25 mg each Aspirin Free Non-Habit Forming 24 GELCAPS

    24 Count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN DIPHENHYDRAMINE HCL 
    acetaminophen diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-988
    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
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorgray (with dark blue opaque and light blue opaque hard gelatin shells) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-988-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/17/2017
    Labeler - FREDS, INC (005866116)