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 Amerisource Bergen for the product Pain Relief Pm (NDC 46122-456). 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, when using this product, 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:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
taking
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
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Compare to Excedrin® PM Headache active ingredients†
NDC 46122-456-71
Pain Relief PM
acetaminophen
aspirin (NSAID) & diphenhydramine citrate
Pain Reliever / Nighttime Sleep Aid
•Caffeine free
50 Caplets ι • 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 Novartis
AG, owner of the registered trademark Excedrin® PM Headache.
50844 ORG011767415
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
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