Excedrin Pm Triple Action Caplets
Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-2056Excedrin Pm Triple Action Caplets also known as Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Excedrin Pm Triple Action Caplets is 0067-2056. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Excedrin Pm Triple Action Caplets drug includes Acetaminophen - 250 mg/1 Aspirin - 250 mg/1 Diphenhydramine Citrate - 38 mg/1 . The currest status of Excedrin Pm Triple Action Caplets drug is Active.
Drug Information:
| Drug NDC: | 0067-2056 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Excedrin Pm Triple Action Caplets |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Aspirin (nsaid) And Diphenhydramine Citrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 250 mg/1
ASPIRIN - 250 mg/1
DIPHENHYDRAMINE CITRATE - 38 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 Sep, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part343 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1593110
1593116
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000000160
N0000008836
M0001335
N0000175722
N0000175578
N0000008832
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
R16CO5Y76E
4OD433S209
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Prostaglandin Production [PE]
Decreased Platelet Aggregation [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Decreased Platelet Aggregation [PE]
Decreased Prostaglandin Production [PE]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0067-2056-24 | 1 BOTTLE in 1 CARTON (0067-2056-24) / 24 TABLET, COATED in 1 BOTTLE | 24 Sep, 2014 | N/A | No |
| 0067-2056-91 | 1 BOTTLE in 1 CARTON (0067-2056-91) / 100 TABLET, COATED in 1 BOTTLE | 24 Sep, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purposes pain reliever pain reliever nighttime sleep-aid
Product Elements:
Excedrin pm triple action caplets acetaminophen, aspirin (nsaid) and diphenhydramine citrate acetaminophen acetaminophen aspirin aspirin diphenhydramine citrate diphenhydramine benzoic acid calcium carbonate fd&c blue no. 1 low-substituted hydroxypropyl cellulose, unspecified hypromellose, unspecified magnesium stearate maltodextrin medium-chain triglycerides polydextrose polysorbate 80 povidone, unspecified starch, corn microcrystalline cellulose stearic acid talc titanium dioxide ferric oxide yellow zinc stearate light blue oblong shaped tablet expm
Indications and Usage:
Uses ⢠for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash 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: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock liver 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 product stomach bleed
Read more...ing 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 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 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 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 doctorâs 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 occur these 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. 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.
Do Not Use:
Warnings reyeâs 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 reyeâs syndrome, a rare but serious illness. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash 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: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock liver 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 product stomach 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 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 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 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 doctorâs 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 occur these 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. 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.
When Using:
When using this product ⢠drowsiness will occur ⢠avoid alcoholic drinks ⢠do not drive a motor vehicle or operate machinery
Dosage and Administration:
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
Stop Use:
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 occur these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel 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 âsealed for your protectionâ is broken or missing distributed by: gsk consumer healthcare warren, nj 07059 ©2015 gsk or its licensor. visit us at www.excedrin.com 46172695 excedrin pm 24 count carton
Further Questions:
Questions or comments? 1-800-452-0051