Active Ingredients (In Each Caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug
Acetaminophen 500 mg
Caffeine 65 mg
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Excedrin Pm Triple Action Caplets And Excedrin Tension Headache (NDC 0067-8147). 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), purposes, 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
Acetaminophen 500 mg
Caffeine 65 mg
Pain Reliever
Pain Reliever
Nighttime sleep-aid
Pain reliever
Pain reliever aid
muscular aches
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:
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:
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
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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat
taking
taking the blood thinning drug warfarin
These could be signs of a serious condition
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 three 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.
ask a health professional before use.
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.
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.
children under 12 years: ask a doctor
read all product information before using. Keep this box for important information.
benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate
benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
1-800-452-0051
1-800-452-0051
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.
NDC 0067-2056-24
EXCEDRIN®
PM HEADACHE
Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate
Pain Reliever/Nighttime Sleep-Aid
Triple Action Formula
Caffeine-Free
Non-Habit Forming
24 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor.
Visit us at www.excedrin.com
46172695
NDC 0067-8139-02
EXCEDRIN®
TENSION HEADACHE
Acetaminophen and Caffeine
Pain Reliever / Pain Reliever Aid
Aspirin Free
100 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare,
Warren, NJ 07059
©2016 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies
Visit us at www.excedrin.com
46177300
* Please review the disclaimer below.