Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Cystex Tablet
FDA Label NDC 69693-417
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands, Llc for the product Cystex (NDC 69693-417). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, indications & usage, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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)
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
Blister Label (Blister)
* Please review the disclaimer below.
