Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • NDC Code(s): 58602-760-14, 58602-760-73
  • Packager: Aurohealth LLC
  • 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 April 9, 2021

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

  • Drug Facts

    Active ingredients (in each gelcap)

    Acetaminophen USP 500 mg
    Diphenhydramine hydrochloride USP 25 mg

  • Purpose

    Pain reliever
    Nighttime sleep aid

  • Uses

    temporary 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

    • with other drugs containing acetaminophen
    • more than 4,000 mg of acetaminophen in 24 hours
    • 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
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product
    • in children under 12 years of age
  • Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the 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 beverages
    • do not drive a motor vehicle or operate machinery
  • Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a 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
    • 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

    • avoid high humidity
    • store at 20º to 25°C (68º to 77°F)
    • use by expiration date on package
  • Inactive ingredients

    ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

  • Questions or comments?

    1-855-274-4122

    Distributed by:
    AUROHEALTH LLC
    279 Princeton- Hightstown Road,
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle)

    AUROHEALTH
    NDC 58602-760-73


    EXTRA STRENGTH
    Acetaminophen and
    Diphenhydramine Hydrochloride
    Gelcaps 500 mg/25 mg
    Pain Reliever,
    Nighttime Sleep Aid

    Non-Habit Forming

    Rapid Release

    20 GELCAPS



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle Carton)

    AUROHEALTH
    Compare to the active ingredients in
    Extra Strength Tylenol® PM
    NDC 58602-760-73

    EXTRA STRENGTH

    Acetaminophen and
    Diphenhydramine
    Hydrochloride Gelcaps 500 mg/25 mg
    Pain Reliever,
    Nighttime sleep aid
    Non-habit forming
    Rapid Release
     20 GELCAPS



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle Carton)
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-760
    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
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (Dark blue and Light blue with white band) Scoreno score
    ShapeCAPSULE (Biconvex) Size20mm
    FlavorImprint Code T;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-760-141 in 1 CARTON01/05/2021
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-760-731 in 1 CARTON01/05/2021
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/05/2021
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-760) , MANUFACTURE(58602-760)