Excedrin Tension Headache
Acetaminophen, Caffeine
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8139Excedrin Tension Headache also known as Acetaminophen, Caffeine is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Excedrin Tension Headache is 0067-8139. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Excedrin Tension Headache drug includes Acetaminophen - 500 mg/1 Caffeine - 65 mg/1 . The currest status of Excedrin Tension Headache drug is Active.
Drug Information:
| Drug NDC: | 0067-8139 |
| 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 Tension Headache |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Excedrin |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Tension Headache |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Caffeine |
| 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, Film 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 - 500 mg/1
CAFFEINE - 65 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: | 15 Dec, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | 307686
404172
|
| 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: | N0000175739
N0000175729
N0000175790
M0023046
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
3G6A5W338E
|
| 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 EPC: | Central Nervous System Stimulant [EPC]
Methylxanthine [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: | Central Nervous System Stimulation [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: | Xanthines [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: | Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Methylxanthine [EPC]
Xanthines [CS]
|
| 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 |
|---|
| 0067-8139-01 | 1 BOTTLE in 1 CARTON (0067-8139-01) / 24 TABLET, FILM COATED in 1 BOTTLE | 15 Dec, 2016 | N/A | No |
| 0067-8139-02 | 1 BOTTLE in 1 CARTON (0067-8139-02) / 100 TABLET, FILM COATED in 1 BOTTLE | 15 Dec, 2016 | 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 aid
Product Elements:
Excedrin tension headache acetaminophen, caffeine acetaminophen acetaminophen caffeine caffeine benzoic acid d&c red no. 27 aluminum lake fd&c blue no. 2 fd&c yellow no. 6 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified starch, corn stearic acid titanium dioxide talc (caplet) eth
Indications and Usage:
Uses ⢠temporarily relieves minor aches and pain due to: ⢠headache ⢠muscular aches
Warnings:
Warnings 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. liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 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 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 heartbeat. do not use ⢠if you are allergic to acetaminophen ⢠with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains
Read more... acetaminophen, ask a doctor or pharmacist. ask a doctor before use if ⢠you have liver disease ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin stop use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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.
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.
Liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 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
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 heartbeat.
Do Not Use:
Warnings 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. liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 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 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 heartbeat. do not use ⢠if you are allergic to acetaminophen ⢠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 ask a doctor or pharmacist before use if you are ⢠taking the blood thinning drug warfarin stop use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days these could be signs of a serious condition if pregnant or breast-feeding, ask a health professional before use. 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.
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.
Liver warning: this product contains acetaminophen. severe liver damage may occur if you take ⢠more than 6 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
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 heartbeat.
Dosage and Administration:
Directions ⢠do not use more than directed ⢠adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours ⢠children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠any new symptoms occur ⢠painful area is red or swollen ⢠pain gets worse or lasts for more than 10 days ⢠fever gets worse or lasts for more than 3 days these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel 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 âsealed for your protectionâ 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 46177300_excedrin tension headache_100 ct.jpg
Further Questions:
Questions or comments? 1-800-452-0051