NDC 0067-2056 Excedrin Pm Triple Action Caplets

Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate

NDC Product Code 0067-2056

NDC CODE: 0067-2056

Proprietary Name: Excedrin Pm Triple Action Caplets What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a blood thinner to prevent blood clots.

NDC Code Structure

  • 0067 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0067-2056-24

Package Description: 1 BOTTLE in 1 CARTON > 24 TABLET, COATED in 1 BOTTLE

NDC 0067-2056-91

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, COATED in 1 BOTTLE

NDC Product Information

Excedrin Pm Triple Action Caplets with NDC 0067-2056 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Excedrin Pm Triple Action Caplets is acetaminophen, aspirin (nsaid) and diphenhydramine citrate. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Excedrin Pm Triple Action Caplets Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 250 mg/1
  • ASPIRIN 250 mg/1
  • DIPHENHYDRAMINE CITRATE 38 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-24-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Aspirin

Aspirin is pronounced as (as' pir in)
Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Excedrin Pm Triple Action Caplets Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Excedrin Pm Headache

[Enter Generic Section here]

Active Ingredients (In Each Caplet)

Acetaminophen 250 mgAspirin 250 mg (NSAID*)Diphenhydramine citrate 38 mg*nonsteroidal anti-inflammatory drug

Acetaminophen 250 mgAspirin 250 mg (NSAID*)Caffeine 65 mg*nonsteroidal anti-inflammatory drug

Purposes

Pain relieverPain relieverNighttime sleep-aid

Pain reliever Pain relieverPain reliever aid

Uses

  • •for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • •temporarily relieves minor aches and pains due to: oheadacheoa coldoarthritisomuscular achesotoothacheopremenstrual & menstrual cramps

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: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf a skin reaction occurs, stop use and seek medical help right away.Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •facial swelling •asthma (wheezing) •shockLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 2 caplets in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productStomach 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 had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) •have 3 or more alcoholic drinks every day while using this product •take more or for a longer time than directed

  • 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: •skin reddening •blisters •rashIf a skin reaction occurs, stop use and seek medical help right away.Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •facial swelling •asthma (wheezing) •shockLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 8 caplets in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productStomach 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 had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) •have 3 or more alcoholic drinks every day while using this product •take more or for a longer time than directedCaffeine 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.

Do Not Use

  • •if you have ever had an allergic reaction to acetaminophen, aspirin or 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

  • •if you have ever had an allergic reaction to acetaminophen, aspirin or 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.

Ask A Doctor Before Use If

  • •you have liver disease •stomach bleeding warning applies to you •you have a history of stomach problems, such as heartburn •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease •you are taking a diuretic •you have asthma •you have glaucoma •you have a breathing problem such as emphysema or chronic bronchitis •you have trouble urinating due to an enlarged prostate gland

  • •you have liver disease •stomach bleeding warning applies to you •you have a history of stomach problems, such as heartburn •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease •you are taking a diuretic •you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking •a prescription drug for: •diabetes •gout •arthritis •any other drug, or are under a doctor’s care for any serious condition •any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer •sedatives or tranquilizers

When Using This Product

  • •drowsiness will occur •avoid alcoholic drinks •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 •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. •pain gets worse or last for more than 10 days •painful area is red or swollen •ringing in the ears or a loss of hearing occurs •any new symptoms occurThese could be signs of a serious condition

  • •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 •painful area is red or swollen •pain gets worse or last for more than 10 days •fever gets worse or lasts for more than 3 days •any new symptoms occurThese could be signs of a serious condition

If Pregnant Or Breast-Feeding,

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. 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.

Keep Out Of Reach Of Children.

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.

Directions

  • •do not use more than directed •do not use in children under 12 years of age •adults and children 12 years of age 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

  • •do not use more than directed •drink a full glass of water with each dose •adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours •children under 12 years: ask a doctor

Other Information

  • •store at 20°-25°C (68°-77°F). •close cap tightly after use. •read all product information before using. Keep this box for important information.

  • •store at 20°-25°C (68°-77°F) •close cap tightly after use •read all product information before using. Keep this box for important information.

Inactive Ingredients

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, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin Extra Strength

[Enter Generic Section here]

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • •a prescription drug for diabetes, gout, or arthritis •any other drug, or are under a doctor’s care for any serious condition

* Please review the disclaimer below.