Label: CYSTEX PM- acetaminophen, diphenhydramine hcl tablet

  • NDC Code(s): 69693-417-10, 69693-417-20
  • Packager: Clarion Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

  • Purpose

    Acetaminophen 500 mg...............................................................Pain reliever
    Diphenhydramine HCl 25 mg ...............................................Nighttime sleep-aid

  • INDICATIONS & USAGE

    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

    • more than 4,000 mg of acetaminophen in 24 hours
    • 3 or more alcoholic drinks every day while using this product
    • with other drugs containing acetaminophen

    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 product containing diphenhydramine, even one used on skin
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • liver disease
    • difficulty in urination due to enlargement of the prostate gland
  • Ask a doctor or pharmacist before use if you are

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

    • do not drive a motor vehicle or operate machinery
    • drowsiness will occur
    • avoid alcoholic beverages
  • Stop use and ask a doctor if

    • 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
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days

    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

    In case of accidental 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 any signs or symptoms.

  • Directions

    • do not take more than directed
    • 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C Red #40 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-844-297-8394

  • PRINCIPAL DISPLAY PANEL

    NEW!

    Cystex® PM

    Acetaminophen
    , Diphenhydramine HCL • Pain Reliever/Nighttime Sleep Aid

    EXTRA STRENGTH PAIN RELIEF

    + SLEEP AID

    Extra strength pain relief
    + sleep aid to help fall asleep

    ZZZ

    Extra strength pain relief
    Safe, non-habit forming

    10 caplets

    actual size

    Guaranteed Satisfaction. If you are not completely satisfied, send us a copy of your cash register receipt, UPC code # along with your full name and address and we will replace or refund your purchase. Limit one refund per household.

    USE ONLY IF BLISTER UNIT IS UNBROKEN

    Cystex is not intended to replace a doctor's care.

    For more information on Cystex tablets or Urinary Tract
    Infections please visit www.cystex.com or call 844-297-8394.

    Distributed by: 
    Cystex LLC 
    27070 Miles Road, Suite A Solon,
    OH 44139    4008A     ©2022

    Carton Label

    Cystex® PM

    Each caplet contains:
    Acetaminophen 500 mg
    Diphenhydramine HCL 25 mg
    Fold along perforations;
    peel back at arrows;
    push product through foil.

    Distributed by: Cystex LLC
    Solon, OH 44139

            Lot# XXXXXXX
            EXP. XX / XX

    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

    Blister Label
  • INGREDIENTS AND APPEARANCE
    CYSTEX   PM
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69693-417
    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
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Fd&C Blue No. 2--Aluminum Lake (UNII: 4AQJ3LG584)  
    Fd&C Red No. 40 (UNII: WZB9127XOA)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Polyvinyl Alcohol, Unspecified (UNII: 532B59J990)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69693-417-201 in 1 CARTON01/28/2022
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69693-417-101 in 1 CARTON06/01/2022
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/28/2022
    Labeler - Clarion Brands, LLC (079742703)