Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 9668a2ca-729e-4172-80b5-33e6c5175ba4

Route

ORAL

Published

Effective Date 2022-04-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Starch, Corn Croscarmellose Sodium Fd&c Blue No. 2--aluminum Lake Fd&c Red No. 40 Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: red Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-01-28

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

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

Medication Information

Indications and Usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Purpose

Acetaminophen 500 mg............................................................... Pain reliever

Diphenhydramine HCl 25 mg ...............................................Nighttime sleep-aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Section 53414-9

If pregnant or breast feeding,ask a health professional before use.

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.

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

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

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

When Using This Product

do not drive a motor vehicle or operate machinery
drowsiness will occur
avoid alcoholic beverages

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

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.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Indications and Usage (34067-9)

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 53414-9 (53414-9)

If pregnant or breast feeding,ask a health professional before use.

Purpose

Acetaminophen 500 mg............................................................... Pain reliever

Diphenhydramine HCl 25 mg ...............................................Nighttime sleep-aid

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.

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

Do Not Use (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

Other Information (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 (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-844-297-8394

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

do not drive a motor vehicle or operate machinery
drowsiness will occur
avoid alcoholic beverages

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children (Keep out of reach of children)

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "53414-9": "If pregnant or breast feeding, ask a health professional before use.", "Purpose": "Acetaminophen 500 mg ............................................................... Pain reliever Diphenhydramine HCl 25 mg ...............................................Nighttime sleep-aid", "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.", "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", "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", "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", "When using this product": "do not drive a motor vehicle or operate machinery drowsiness will occur avoid alcoholic beverages", "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", "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.", "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.", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.680006 · Updated: 2026-03-14T23:11:56.566307