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 18, 2017

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

  • Active ingredients

    (in each caplet)

    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

    ■ 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 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 caplets at bedtime
    ■ do not take more than 2 caplets 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

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, polysorbate 80, polyethylene glycol, povidone k-30, stearic acid, titanium dioxide

  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, polysorbate 80, polyethylene glycol, povidone k-30, stearic acid, titanium dioxide

  • Questions or comments?

    cal l 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 Asprin Free Non Habit-Forming 100 CAPLETS+ (+ Capsule-Shaped Tablets)

    100 count

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN DIPHENHYDRAMINE HCL 
    acetaminophen diphenhydramine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-990
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code G651
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-990-10100 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)