Rite Aid 44-235

SPL v27

SPL

SPL Set ID 17d27771-a112-474f-9a58-29af0d7e1af3

Route

ORAL

Published

Effective Date 2025-07-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Starch, Corn Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;235 Shape: oval Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 1994-05-15 Until 2021-10-16

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep-aid

Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

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
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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
in children under 12 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have ever had an allergic reaction to this product or any of its ingredients

Other Information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 11822-2350-5

Compare to the active ingredients

of Extra Strength Tylenol^® PM*

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN PM

ACETAMINOPHEN 500 mg • DIPHENHYDRAMINE HCl 25 mg

PAIN RELIEVER/NIGHTTIME SLEEP AID

non-habit forming

ACTUAL SIZE

50

CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark Extra

Strength Tylenol^® PM.

50844 REV0521F23515

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Rite Aid 44-235

When Using This Product

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

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.

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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
liver disease
glaucoma
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

Structured Label Content

Uses

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

Purpose

Pain reliever

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
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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
in children under 12 years of age
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you have ever had an allergic reaction to this product or any of its ingredients

Other Information (Other information)

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

NDC 11822-2350-5

Compare to the active ingredients

of Extra Strength Tylenol^® PM*

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN PM

ACETAMINOPHEN 500 mg • DIPHENHYDRAMINE HCl 25 mg

PAIN RELIEVER/NIGHTTIME SLEEP AID

non-habit forming

ACTUAL SIZE

50

CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark Extra

Strength Tylenol^® PM.

50844 REV0521F23515

DISTRIBUTED BY:

RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319 www.riteaid.com

SATISFACTION

GUARANTEE

If you're not satisfied, we'll

happily refund your money.

Rite Aid 44-235

When Using This Product (When using this product)

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

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 Before Use If You Have (Ask a doctor before use if you have)

a breathing problem such as emphysema or chronic bronchitis
liver disease
glaucoma
difficulty in urination due to enlargement of the prostate gland

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)

{"Uses": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "Purpose": "Pain reliever 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 with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients", "Other information": "store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number", "Inactive ingredients": "colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "NDC 11822-2350-5 Compare to the active ingredients of Extra Strength Tylenol ® PM* EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN PM ACETAMINOPHEN 500 mg • DIPHENHYDRAMINE HCl 25 mg PAIN RELIEVER/NIGHTTIME SLEEP AID non-habit forming ACTUAL SIZE 50 CAPLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Extra Strength Tylenol ® PM. 50844 REV0521F23515 DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com SATISFACTION GUARANTEE If you're not satisfied, we'll happily refund your money. Rite Aid 44-235", "When using this product": "avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery", "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. ", "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.", "Active ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:34.816646 · Updated: 2026-03-14T23:09:25.529071