Label: LEGATRIN PM- acetaminophen, diphenhydramine hci 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 October 1, 2019

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

  • Active ingredients (in each caplet)

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCI 50 mg

  • Purposes

    Purposes

    Acetaminophen - Pain Reliever

    Diphenhydramine HCI - Sleep Aid

  • Uses

    Uses

    temporary relief of minor aches and pains, such as leg cramp pain, joint pain, lower backache, and sore feet, with accompanying sleeplessness.

  • Warnings

    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
    • 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

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a docotr or pharmacist.
    • with any other product containing dephenhydramine, 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
    • breathing problem such as asthma, emphysema, chronic bronchitis or pulmonary disease
    • trouble urinating due to an enlarged prostate gland
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor or pharmacist before use if you are

    • taking tranquilizers or sedatives
    • taking the blood thinning drug warfarin
  • When using this product

    When using this product

    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery
    • avoid alcoholic drinks
  • Stop Use

    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 for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • symptoms do not improve within 7 days or are accompanied by a fever
    • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur

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

  • Keep out of reach of children

    Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    • Do not exceed recommended dosage.

    Adults and children 12 years of age and older

    1 caplet at bedtime as needed, or as directed by a doctor
    Children under 12 yearsconsult a doctor

  • Other Information

    Other information

    • store at controlled room temperature 20° to 25° C (68° to 77° F)
    • avoid excessive heat and humidity
    • tamper evident. Do not use if carton is opened or neck wrap or foil inner seal is broken.
    • see end panel for lot number and expiration date.
  • Inactive Ingredients

    Inactive ingredients

    colloidal silicon dioxide, corn starch, FD&C blue #1, hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid

  • Package Label. Principal Display Panel LegatrinPM

    Just 1 caplet

    helps you sleep!

    SAFE, NON-HABIT FORMING

    Contains Acetaminophen,

    Diphenhydramine HCI

    LegatrinPM

    Pain Reliever/Sleep Aid

    Relieves lower

    body pain

    Leg Cramp Pain

    Joint Pain

    Lower Backache

    Sore Feet

    50 Caplets

    LGFC-00114-03

  • INGREDIENTS AND APPEARANCE
    LEGATRIN PM 
    acetaminophen, diphenhydramine hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-907
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code Legatrin
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-907-501 in 1 CARTON10/01/2014
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/01/2014
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812label(10237-907)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRAtab151051757manufacture(10237-907)