Acetaminophen 250mg Aspirin 250mg Caffeine 65mg

Cvs Pharmacy
Human Otc Drug
NDC 69842-592

Acetaminophen 250mg Aspirin 250mg Caffeine 65mg is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Acetaminophen 250mg Aspirin 250mg Caffeine 65mg is 69842-592. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Acetaminophen 250mg Aspirin 250mg Caffeine 65mg drug includes Acetaminophen - 250 mg/1 Aspirin - 250 mg/1 Caffeine - 65 mg/1 . The currest status of Acetaminophen 250mg Aspirin 250mg Caffeine 65mg drug is Active.

Drug Information:

Drug NDC:	69842-592
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:	Acetaminophen 250mg Aspirin 250mg Caffeine 65mg
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 250mg Aspirin 250mg Caffeine 65mg
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Cvs Pharmacy
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	01 Feb, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 Jan, 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, 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:	CVS Pharmacy
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	308297
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 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
69842-592-23	20 TABLET in 1 BOTTLE (69842-592-23)	01 Feb, 2021	N/A	No
69842-592-80	80 TABLET in 1 BOTTLE (69842-592-80)	01 Feb, 2021	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.

Other medicines with the same generic name

Purpose:

Pain reliever pain reliever pain reliever aid

Product Elements:

Acetaminophen 250mg aspirin 250mg caffeine 65mg acetaminophen 250mg aspirin 250mg caffeine 65mg acetaminophen acetaminophen fd&c red no. 40 gelatin d&c yellow no. 10 propylene glycol stearic acid titanium dioxide light mineral oil ethylcellulose, unspecified glycerin lactose monohydrate anhydrous lactose povidone, unspecified aspirin aspirin caffeine caffeine ferrosoferric oxide fd&c blue no. 1 starch, corn ammonia microcrystalline cellulose sorbitol solution talc shellac triacetin hypromelloses dark green - white s77

Indications and Usage:

Temporarily relieves minor aches and pains due to: headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps

Warnings:

Reyes 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 reyes 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 8 geltabs in 24 hours, which is the maximum daily amount, with other drugs contains acetaminophen, 3 or more alcoholic drinks every day while using this product. stomach bleeding warning: this contains an nsaid, which mat cause severe stomach bleeding. t Read more...

he 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 product, take more or for a longer time than direct. 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 have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/ fever, 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. 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 doctors 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 loss of hearing occurs, 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, 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 3 months of pregnancy unless definitely 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.

Dosage and Administration:

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

Package Label Principal Display Panel:

342594 342590

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.