Drugplain

PM Headache 250 mg/1

Acetaminophen, Aspirin, Diphenhydramine citrate · TABLET, FILM COATED · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

No Recall HistoryCurrently in Shortage
Plain English

PM Headache is a tablet, film coated containing acetaminophen, aspirin, diphenhydramine citrate at 250 mg/1, taken oral. Manufactured by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Key Facts

Brand Name
PM Headache
Generic Name
Acetaminophen, Aspirin, Diphenhydramine citrate
NDC Code (Product)
51316-674
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
09/11/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

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 nonprescr

Frequently Asked Questions

What is PM Headache used for?

PM Headache contains Acetaminophen, Aspirin, Diphenhydramine citrate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is PM Headache a controlled substance?

PM Headache is not classified as a controlled substance by the DEA.

What is the generic name for PM Headache?

The generic name for PM Headache is Acetaminophen, Aspirin, Diphenhydramine citrate. There are 2 other brand versions of Acetaminophen, Aspirin, Diphenhydramine citrate.

What is the NDC code for PM Headache 250 mg/1?

The NDC (National Drug Code) for PM Headache 250 mg/1 is 51316-674, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Product NDC

51316-674

Package NDC

51316-674-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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