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  5. Label Information: Cystex PM

FDA Label for Cystex PM

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Cystex PM Product Label

The following document was submitted to the FDA by the labeler of this product Clarion Brands, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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

20 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
infection 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 - carton

Carton Label - carton

Cystex®PM

Each caplet contains:
Acetaminophen 500 mg
Diphenhydramine HCL 25 mg
Fold along perforations;
peel back at arrows;
push product through foil.
Mfd. by LNK International, Inc.,
Hauppague, NY 11788
        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 hour
● with other drugs containing acetaminophen
● 3 or more alcoholic drinks every day while using this product


* Please review the disclaimer below.