Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Pain Relief Pm (NDC 59779-894). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
Nighttime sleep-aid
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
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:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
These could be signs of a serious condition
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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.
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
1-800-426-9391
♥︎CVS Health™
Compare to the active ingredients
in Excedrin® PM Headache†
Caplets
NDC 59779-894-12
Pain Relief PM
ACETAMINOPHEN, 250 mg
ASPIRIN (NSAID), 250 mg
DIPHENHYDRAMINE CITRATE, 38 mg
Pain reliever, Nighttime sleep-aid
• Non-habit forming
• For pain with sleeplessness
100 CAPLETS
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
Novartis Consumer Health, Inc., owner of the
registered trademark Excedrin® PM Headache.
50844 ORG031667412
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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