Acetaminophen And Diphenhydramine Hcl Tablets

SPL v1

SPL

SPL Set ID 778465c5-6606-4e3a-bb7b-7a4dcebf15c5

Route

ORAL

Published

Effective Date 2014-05-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Hypromelloses Cellulose, Microcrystalline Povidone K30 Stearic Acid Titanium Dioxide Polyethylene Glycols Fd&c Blue No. 1 Fd&c Blue No. 2 Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: S525 Shape: oval Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-06-01

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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
pain gets worse or lasts for more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

Section 50567-7

When using this product

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

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

liver cirrhosis
asthma
breathing problems such as emphysema or chronic bronchitis
trouble in urinating due to an enlargement of the prostate gland
glaucoma

Section 50570-1

Do not use

with other products 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
with any other products containing diphenhydramine, even one used on skin
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Section 53414-9

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

Section 55105-1

Active ingredients (in each caplet)	Purpose
Acetaminophen 500mg	Pain reliever
Diphenhydramine HCl 25mg	Nighttime Sleep aid

Directions

do not take more than recommended (see overdose warning)

adults and children 12 years of age and over:	take 2 caplets at bedtime or as directed by a doctor do not take more than 2 caplets in a 24 hour period
children under 12 years of age:	do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Liver Warning

This product contains acetaminophen. Severe liver damage may occur with this product if you take

more than 2 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while you are using this product

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

store at 20°-25°C (68°-77°F)
see end panel for lot number and expiration
each tablet contains: magnesium 0.05 mg

Inactive Ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

Questions Or Comments?

1-888-287-1915

Principal Display Panel 50 Caplet Bottle Carton

NDC 49035-026-50

equate^®

Compare to

Extra Strength

Tylenol® PM

Active

Ingredients*

Extra Strength

Acetaminophen PM

Acetaminophen 500 mg , Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep Aid

Aspirin Free

Non-Habit Forming

50

CAPLETS

Actual Size

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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
pain gets worse or lasts for more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver cirrhosis
asthma
breathing problems such as emphysema or chronic bronchitis
trouble in urinating due to an enlargement of the prostate gland
glaucoma

Section 50570-1 (50570-1)

Do not use

with other products 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
with any other products containing diphenhydramine, even one used on skin
if you are allergic to acetaminophen or any of the inactive ingredients in this product

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each caplet)	Purpose
Acetaminophen 500mg	Pain reliever
Diphenhydramine HCl 25mg	Nighttime Sleep aid

Directions

do not take more than recommended (see overdose warning)

adults and children 12 years of age and over:	take 2 caplets at bedtime or as directed by a doctor do not take more than 2 caplets in a 24 hour period
children under 12 years of age:	do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur with this product if you take

more than 2 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while you are using this product

Overdose Warning

Other Information (Other information)

store at 20°-25°C (68°-77°F)
see end panel for lot number and expiration
each tablet contains: magnesium 0.05 mg

Inactive Ingredients (Inactive ingredients)

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-287-1915

Principal Display Panel 50 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton)

NDC 49035-026-50

equate^®

Compare to

Extra Strength

Tylenol® PM

Active

Ingredients*

Extra Strength

Acetaminophen PM

Acetaminophen 500 mg , Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep Aid

Aspirin Free

Non-Habit Forming

50

CAPLETS

Actual Size

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "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 pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.", "50567-7": "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have liver cirrhosis asthma breathing problems such as emphysema or chronic bronchitis trouble in urinating due to an enlargement of the prostate gland glaucoma", "50570-1": "Do not use with other products 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 with any other products containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Diphenhydramine HCl 25mg Nighttime Sleep aid", "Directions": "do not take more than recommended (see overdose warning ) adults and children 12 years of age and over: take 2 caplets at bedtime or as directed by a doctor do not take more than 2 caplets in a 24 hour period children under 12 years of age: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur with this product if you take more than 2 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while you are using this product", "Overdose Warning": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "store at 20°-25°C (68°-77°F) see end panel for lot number and expiration each tablet contains: magnesium 0.05 mg", "Inactive ingredients": "FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide", "Questions or comments?": "1-888-287-1915", "PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton": "NDC 49035-026-50 equate ® Compare to Extra Strength Tylenol® PM Active Ingredients* Extra Strength Acetaminophen PM Acetaminophen 500 mg , Diphenhydramine HCl 25 mg Pain Reliever/Nighttime Sleep Aid Aspirin Free Non-Habit Forming 50 CAPLETS Actual Size"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.251381 · Updated: 2026-03-14T22:53:45.227062