0752-cvs
6df9a638-09dd-166f-e053-2991aa0a8dd0
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Purpose
Pain reliever and Nighttime sleep-aid
Medication Information
Warnings and Precautions
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.
Purpose
Pain reliever and Nighttime sleep-aid
Description
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Section 34088-5
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 42229-5
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 Tylenol® PM Extra Strength.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34571
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.
- 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.
Section 50567-7
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- drowsiness will occur
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 disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Section 50570-1
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
Section 51727-6
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
Section 51945-4
CVS
NDC 69842-572-12
Extra Strength
ACETAMINOPHEN PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever, Nighttime Sleep-Aid
Compare to Tylenol® PM Extra Strength active ingredients*
100 CAPLETS
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Other Information
- Store in a dry place at 15°-30°C (59°-86°F).
- see end flap for expiration date and lot number
Questions Or Comments?
1-800-231-4670
Structured Label Content
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings and Precautions (34071-1)
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.
Section 34088-5 (34088-5)
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 42229-5 (42229-5)
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 Tylenol® PM Extra Strength.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34571
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.
- 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.
Section 50567-7 (50567-7)
When using this product
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
- drowsiness will occur
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 disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
Section 51945-4 (51945-4)
CVS
NDC 69842-572-12
Extra Strength
ACETAMINOPHEN PM
Acetaminophen, 500 mg
Diphenhydramine HCl, 25 mg
Pain Reliever, Nighttime Sleep-Aid
Compare to Tylenol® PM Extra Strength active ingredients*
100 CAPLETS
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Purpose
Pain reliever and Nighttime sleep-aid
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
Drug Facts
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Other Information (Other information)
- Store in a dry place at 15°-30°C (59°-86°F).
- see end flap for expiration date and lot number
Questions Or Comments? (Questions or comments?)
1-800-231-4670
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:17.931943 · Updated: 2026-03-14T23:08:59.288880