NDC 0067-8148 Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever

Acetaminophen, Aspirin (nsaid), Caffeine, And Diphenhydramine Citrate

NDC Product Code 0067-8148

NDC CODE: 0067-8148

Proprietary Name: Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever 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), Caffeine, 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.

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT BLUE)
WHITE (C48325 - WHITE)
Shape: RECTANGLE (C48347)
CAPSULE (C48336)
Size(s):
17 MM
18 MM
Imprint(s):
EXPM
E
Score: 1

NDC Code Structure

  • 0067 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    • 0067-8148 - Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever

NDC 0067-8148-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 1 BOTTLE in 1 CARTON (0067-2056-24) > 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-2000-91) > 100 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever with NDC 0067-8148 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 And Excedrin Extra Strength Pain Reliever is acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate. The product's dosage form is kit and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Kit - A packaged collection of related material.

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.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 05-01-2018 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.

Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever Product Label Images

Excedrin Pm Triple Action Caplets And Excedrin Extra Strength Pain Reliever 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.