Equaline 44-556

SPL v15

SPL

SPL Set ID ae3114c3-8cfe-4b81-8ac7-c281fe68b462

Route

ORAL

Published

Effective Date 2025-02-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Ammonia Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Red No. 3 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L;6 Shape: oval Color: blue Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2007-12-17 Until 2018-03-17

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 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
children under 12 years: do not use

Do Not Use

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.
with any other product containing diphenhydramine, even one used on skin
if you have ever had an allergic to this product or any of its ingredients

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
avoid high humidity

Inactive Ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Questions Or Comments?

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Extra Strength Tylenol^® PM

active ingredients*

NDC 41163-956-09

extra strength

acetaminophen PM gelcaps

acetaminophen 500 mg

diphenhydramine HCl 25 mg

pain reliever/nighttime sleep aid

20 gelcaps

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Extra Strength Tylenol^®PM.

100 % Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

50844 REV0322H55609

Equaline 44-556

When Using This Product

drowsiness will occur
avoid alcoholic beverages
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 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 Gelcap)

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
difficulty in urination due to enlargement of the prostate gland
glaucoma

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 gelcaps at bedtime
- do not take more than 2 gelcaps of this product in 24 hours
children under 12 years: do not use

Do Not Use (Do not use)

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.
with any other product containing diphenhydramine, even one used on skin
if you have ever had an allergic to this product or any of its ingredients

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
avoid high humidity

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Extra Strength Tylenol^® PM

active ingredients*

NDC 41163-956-09

extra strength

acetaminophen PM gelcaps

acetaminophen 500 mg

diphenhydramine HCl 25 mg

pain reliever/nighttime sleep aid

20 gelcaps

actual size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the

registered trademark Extra Strength Tylenol^®PM.

100 % Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

50844 REV0322H55609

Equaline 44-556

When Using This Product (When using this product)

drowsiness will occur
avoid alcoholic beverages
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 Gelcap) (Active ingredients (in each gelcap))

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
difficulty in urination due to enlargement of the prostate gland
glaucoma

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 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years: do not use ", "Do not use": "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. with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic to this product or any of its ingredients ", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number avoid high humidity", "Inactive ingredients": "ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide ", "Questions or comments?": "1-855-423-2630", "Principal Display Panel": "EQUAL INE® compare to Extra Strength Tylenol ® PM active ingredients* NDC 41163-956-09 extra strength acetaminophen PM gelcaps acetaminophen 500 mg diphenhydramine HCl 25 mg pain reliever/nighttime sleep aid 20 gelcaps actual size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol ® PM. 100 % Quality GUARANTEED DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 50844 REV0322H55609 Equaline 44-556", "When using this product": "drowsiness will occur avoid alcoholic beverages 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 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 gelcap)": "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 difficulty in urination due to enlargement of the prostate gland glaucoma", "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: 2026-02-15T12:05:34.377799 · Updated: 2026-03-14T23:07:36.685051