Tylenol ® - DailyMed Details

Tylenol ®

SPL v11

SPL

SPL Set ID 643371f2-e330-441e-8932-b3aec4b179d2

Route

ORAL

Published

Effective Date 2022-10-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg) Acetaminophen (500 mg)

Inactive Ingredients

Carnauba Wax Crospovidone (15 Mpa.s At 5%) Fd&c Blue No. 1 Aluminum Oxide Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Magnesium Stearate Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: TY;PM Shape: oval Color: blue Size: 19 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-04-19 Until 2028-08-12

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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 53414-9

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

Section 55105-1

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

Directions

do not take more than directed (see overdose warning)

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 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
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

Tylenol ®

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid Non-habit forming

[caplets image]

4

Caplets

2 POUCHES OF 2 CAPLETS EACH

[Travel BASIX logo]

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

Overdose Warning

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 between 20-25°C (68-77°F)
do not use if pouch is torn or damaged

Inactive Ingredients

carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

When Using This Product

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

Extra Strength Tylenol ®

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid

Non-habit forming

[caplets image]

4

Caplets

2 POUCHES OF 2 CAPLETS EACH

[CVP _® HEALTH logo]

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Principal Display Panel 6 Caplet Pouch Carton

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid

Non-habit forming

6

Caplets

3 POUCHES OF 2 CAPLETS EACH

Lil'

DrugStore ^®

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 500 mg	Pain reliever
Diphenhydramine HCl 25 mg	Nighttime sleep aid

Directions

do not take more than directed (see overdose warning)

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 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
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

Tylenol ®

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid Non-habit forming

[caplets image]

4

Caplets

2 POUCHES OF 2 CAPLETS EACH

[Travel BASIX logo]

Liver Warning (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

Overdose Warning (Overdose warning)

Other Information (Other information)

store between 20-25°C (68-77°F)
do not use if pouch is torn or damaged

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

When Using This Product (When using this product)

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

Extra Strength Tylenol ®

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid

Non-habit forming

[caplets image]

4

Caplets

2 POUCHES OF 2 CAPLETS EACH

[CVP _® HEALTH logo]

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 serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

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

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Principal Display Panel 6 Caplet Pouch Carton (PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton)

Extra Strength

TYLENOL ^®

PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever, Nighttime Sleep Aid

Non-habit forming

6

Caplets

3 POUCHES OF 2 CAPLETS EACH

Lil'

DrugStore ^®

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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"strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": 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Raw Label Data

All Sections (JSON)

{"Uses": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid", "Directions": "do not take more than directed (see overdose warning ) 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 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 in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients", "Tylenol ®": "Extra Strength TYLENOL ® PM Acetaminophen , Diphenhydramine HCl Pain Reliever, Nighttime Sleep Aid Non-habit forming [caplets image] 4 Caplets 2 POUCHES OF 2 CAPLETS EACH [Travel BASIX logo]", "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", "Overdose warning": "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 between 20-25°C (68-77°F) do not use if pouch is torn or damaged", "Inactive ingredients": "carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide", "Questions or comments?": "call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "When using this product": "drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "Extra Strength Tylenol ®": "Extra Strength TYLENOL ® PM Acetaminophen , Diphenhydramine HCl Pain Reliever, Nighttime Sleep Aid Non-habit forming [caplets image] 4 Caplets 2 POUCHES OF 2 CAPLETS EACH [CVP ® HEALTH logo]", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.", "Ask a doctor before use if you have": "liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma", "PRINCIPAL DISPLAY PANEL - 6 Caplet Pouch Carton": "Extra Strength TYLENOL ® PM Acetaminophen, Diphenhydramine HCl Pain Reliever, Nighttime Sleep Aid Non-habit forming 6 Caplets 3 POUCHES OF 2 CAPLETS EACH Lil' DrugStore ®", "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: 2026-02-15T12:07:36.821499 · Updated: 2026-03-14T23:11:16.641314