Headache Relief Extra Strength
Acetaminophen, Aspirin And Caffeine
Great Lakes Wholesale, Marketing, & Sales, Inc.
Human Otc Drug
NDC 64092-112Headache Relief Extra Strength also known as Acetaminophen, Aspirin And Caffeine is a human otc drug labeled by 'Great Lakes Wholesale, Marketing, & Sales, Inc.'. National Drug Code (NDC) number for Headache Relief Extra Strength is 64092-112. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Headache Relief Extra Strength drug includes Acetaminophen - 250 mg/1 Aspirin - 250 mg/1 Caffeine - 65 mg/1 . The currest status of Headache Relief Extra Strength drug is Active.
Drug Information:
| Drug NDC: | 64092-112 |
| 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: | Headache Relief Extra Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Headache Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Extra Strength |
| 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, Aspirin And Caffeine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Great Lakes Wholesale, Marketing, & Sales, Inc. |
| 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 - 250 mg/1
ASPIRIN - 250 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: | 17 Nov, 1992 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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, 2024 |
| 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: | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0792215801120
|
| UPC stands for Universal Product Code. |
| NUI: | N0000000160
N0000008836
M0001335
N0000175722
N0000175578
N0000008832
N0000175739
N0000175729
N0000175790
M0023046
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
R16CO5Y76E
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 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]
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: | Decreased Prostaglandin Production [PE]
Decreased Platelet Aggregation [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: | Anti-Inflammatory Agents, Non-Steroidal [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: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Cyclooxygenase Inhibitors [MoA]
Decreased Platelet Aggregation [PE]
Decreased Prostaglandin Production [PE]
Methylxanthine [EPC]
Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [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 |
|---|
| 64092-112-50 | 1 BOTTLE, PLASTIC in 1 CARTON (64092-112-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 17 Nov, 1992 | 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:
Purpose pain reliever pain reliever pain reliever aid
Product Elements:
Headache relief extra strength acetaminophen, aspirin and caffeine acetaminophen acetaminophen aspirin aspirin caffeine caffeine starch, corn crospovidone, unspecified hypromellose, unspecified microcrystalline cellulose povidone, unspecified propylene glycol sodium lauryl sulfate sodium starch glycolate type a potato stearic acid titanium dioxide 44;159
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: toothache arthritis a cold headache muscular aches premenstrual and menstrual cramps
Warnings:
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: aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) 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 4,000 mg of acetaminophen in 24 hours 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 i
Read more...s 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 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition 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 ringing in the ears or a loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present 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 3 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 accidental overdose, get medical help or contact a poison control center right away. prompt 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 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: aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) 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 4,000 mg of acetaminophen in 24 hours 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 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. 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition 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 ringing in the ears or a loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present 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 3 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 accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage and Administration:
Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours. do not take more than 8 tablets in 24 hours. children under 12 years: ask 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 ringing in the ears or a loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel health care⢠ndc 64092-112-50 â compare to the active ingredients in excedrin® extra strength extra strength headache relief acetaminophen, aspirin (nsaid) and caffeine pain reliever, pain reliever aid for pain of headaches, arthritis and muscular aches actual size 50 tablets tamper evident: do not use if imprinted safety seal under cap is broken or missing healthcare guarantee if you are not completely satisfied with this product, regardless of reason, return your unused portion to great lakes wholesale for a full refund â this product is not manufactured or distributed by gsk consumer healthcare s.a., owner of the registered trademark excedrin® extra strength. 50844 rev1119l15915 distributed by: great lakes wholesale & marketing l.l.c. 3729 patterson ave., s.e., grand rapids, mi 49512 www.glwholesale.com healthcare 44-159b healthcare 44-159b
Further Questions:
Questions or comments? call 1-800-426-9391