Quick answers
- What is Acetaminophen, aspirin and diphenhydramine used for?
- The Drug Facts label of Pain Relief PM (CVS Pharmacy) lists these uses: for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
- Do I need a prescription for Acetaminophen, aspirin and diphenhydramine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Acetaminophen, aspirin and diphenhydramine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Pain Relief PM · CVS Pharmacy
Acetaminophen 250 mg · Aspirin 250 mg · Diphenhydramine citrate 38 mg, tablet, film coated (oral)
Active ingredient (in each caplet)
Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever Nighttime sleep-aid
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
- Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
When using this product
if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
- Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing)
- Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away.
- 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
- Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product
Do not use
if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer 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
Ask a doctor before use if
stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have difficulty in urination due to enlargement of the prostate gland you have liver disease you have a breathing problem such as emphysema or chronic bronchitis you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have glaucoma you have asthma
Ask a doctor or pharmacist before use if
you are taking a prescription drug for: diabetes gout arthritis any other drug, or are under a doctor’s care for any serious condition sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
When using this product
avoid alcoholic beverages drowsiness may occur do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs 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 redness or swelling is present new symptoms occur These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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.
Directions
do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years: do not use
Inactive ingredients
corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate
Questions?
1-800-426-9391
— FDA label of Pain Relief PM, CVS Pharmacy, effective February 11, 2026. See the official label on DailyMed →
Excedrin PM Triple Action Caplets · Haleon US Holdings LLC
Acetaminophen 250 mg · Aspirin 250 mg · Diphenhydramine citrate 38 mg, tablet, coated (oral)
Active ingredient (in each caplet)
Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever Pain Reliever Nighttime sleep-aid
Uses
- for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
- Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
When using this product
if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
- 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.
- Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- Liver warning: This product contains acetaminophen. Severe liver damage may occur 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 using this product
- Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- 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
Ask a doctor before use if
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have glaucoma
- you have a breathing problem such as emphysema or chronic bronchitis
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if
you are taking
- a prescription drug for:
- diabetes
- gout
- arthritis
- any other drug, or are under a doctor’s care for any serious condition
- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
- sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or last for more than 10 days
- painful area is red or swollen
- ringing in the ears or a loss of hearing occurs
- any new symptoms occur These could be signs of a serious condition
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- do not use in children under 12 years of age
- adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water
- do not take more than 2 caplets in 24 hours, unless directed by a doctor
Inactive ingredients
benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate
Questions?
1-800-468-7746
— FDA label of Excedrin PM Triple Action Caplets, Haleon US Holdings LLC, effective March 14, 2024. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Acetaminophen 250 mg · Aspirin 250 mg · Diphenhydramine citrate 38 mg · tablet, film coated (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Pain Relief PM | CVS Pharmacy | DailyMed |
| PM Headache | Cvs Woonsocket Prescription Center, Incorporated | — |
Acetaminophen 250 mg · Aspirin 250 mg · Diphenhydramine citrate 38 mg · tablet, coated (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Excedrin PM Triple Action Caplets | Haleon US Holdings LLC | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Haleon US Holdings LLC1 product
- Cvs Woonsocket Prescription Center, Incorporated1 product
- CVS Pharmacy1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youA pharmacist can answer questions about this label
- Latest FDA drug recallsPrescription and over-the-counter, newest first
- All over-the-counter medicinesSearch by ingredient, brand or Spanish name
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.