Label: ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG- acetaminophen / diphenhydramine 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 January 28, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Acetaminophen 500 mg

    Diphenhydramine HCL 25 mg

  • PURPOSE

    Pain reliever

    Nighttime sleep aid

  • INDICATIONS & USAGE

    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 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
  • OTHER SAFETY INFORMATION

    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

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If ypu are not sure whether a drug contains acetaminophen, ask doctor or pharmacist.
    • with any other drug containing diphenhydramine, even one used on skin
    • in children under 12 years of age
  • ASK DOCTOR

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Drug Facts continued on back of label

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

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

  • WHEN USING

    When using this product

    • marked drowsiness will occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase droqsiness
    • do not drive a motor vehicle or operate machinery
  • STOP USE

    Stop use and ask a doctor if

    • sleeplessness lasts 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 for more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

  • PREGNANCY 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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Incase of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice 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 if needed
    • do not take more than directed

    children under 12 years: do not use

  • Other information

    store at room temperature 15º-30ºC (59º-86ºF)

  • INACTIVE INGREDIENT

    croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide

  • QUESTIONS

    call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    369618013056-Acetaminophen-Diphenhydramine 500-25 mg CapletsNDC 69618-013-05

    Acetaminophen 500 mg & Diphenhydramine HCL 25 mg

    PAIN RELIEVER

    NIGHTTIME SLEEP AID

    50 CAPLETS

    *Compare to Active Ingredients in Tylenol® PM

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG 
    acetaminophen / diphenhydramine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVALSize7mm
    FlavorImprint Code AP;133
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-013-0550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)