Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet

  • NDC Code(s): 21130-224-18, 21130-224-73
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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 a 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:
    BETTER LIVING BRANDS LLC
    P.O.BOX 99, PLEASANTON,
    CA 94566-0009,
    1-888-723-3929

    Made in India

    Code: TS/DRUGS/16/2014

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

    NDC 21130-224-73

    Signature
    care ®
    Quality
    Guaranteed

    Extra Strength
    Pain Relief PM

    ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE
    HYDROCHLORIDE 25 mg
    GELCAPS

    Pain Reliever/Nighttime Sleep Aid

    Non-habit forming

    RAPID RELEASE

    20 GELCAPS


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

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

    Signature
    care
    ®
    Quality
    Guaranteed

    Compare to
    Extra Strength
    TYLENOL ®PM
    active ingredient *

    NDC 21130-224-73

    Extra Strength
    Pain Relief PM

    ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE
    HYDROCHLORIDE 25 mg
    GELCAPS

    Pain Reliever/Nighttime Sleep Aid

    Non-habit forming

    RAPID RELEASE

    Actual Size

    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:21130-224
    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:21130-224-731 in 1 CARTON11/18/2023
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21130-224-181 in 1 CARTON11/18/2023
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/18/2023
    Labeler - Better Living Brands, LLC (009137209)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777analysis(21130-224) , manufacture(21130-224)