Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel Nighttime Headache Relief ♥CVS™ NDC 51316-674-12 PM HEADACHE Acetaminophen , 250 mg | Aspirin (NSAID) , 250 mg Diphenhydramine Citrate, 38 mg Pain Reliever, Nighttime Sleep-Aid Compare to Excedrin® PM Headache active ingredients † 100 CAPLETS Caffeine Free Non-Habit Forming 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 Haleon CH SARL, owner of the registered trademark Excedrin® PM Headache. 50844 ORG122467412 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-674 CVS 44-674
- Principal Display Panel Nighttime Headache Relief ♥CVS™ NDC 51316-674-12 PM HEADACHE Acetaminophen , 250 mg | Aspirin (NSAID) , 250 mg Diphenhydramine Citrate, 38 mg Pain Reliever, Nighttime Sleep-Aid Compare to Excedrin® PM Headache active ingredients † 100 CAPLETS Caffeine Free Non-Habit Forming 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 Haleon CH SARL, owner of the registered trademark Excedrin® PM Headache. 50844 ORG122467412 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2025 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-674 CVS 44-674
Overview
Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Indications & Usage
Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Dosage & Administration
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
Warnings & Precautions
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 have 3 or more alcoholic drinks every day while using this product 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 Do not use if you have ever had an allergic reaction to 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease you have glaucoma you have asthma you have a breathing problem such as emphysema or chronic bronchitis you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness will 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 more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose
Purpose Pain reliever Pain reliever Nighttime sleep-aid
Do Not Use
Do not use if you have ever had an allergic reaction to 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
When Using
When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery
Stop Use & Ask a Doctor
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 more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear
Keep Out of Reach of Children
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.
Storage & Handling
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
Questions
Questions or comments? 1-800-426-9391
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