CYSTEX PM- acetaminophen, diphenhydramine hcl tablet

Cystex by

Drug Labeling and Warnings

Cystex by is a Otc medication manufactured, distributed, or labeled by Clarion Brands, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

CYSTEX   PM
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-417
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-417-20	1 in 1 CARTON	01/28/2022
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 69693-417-10	1 in 1 CARTON	06/01/2022
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/28/2022

Labeler - Clarion Brands, LLC (079742703)