Ibuprofen And Pseudoephedrine Hcl

Cvs Pharmacy, Inc.
Human Otc Drug
NDC 69842-092

Ibuprofen And Pseudoephedrine Hcl is a human otc drug labeled by 'Cvs Pharmacy, Inc.'. National Drug Code (NDC) number for Ibuprofen And Pseudoephedrine Hcl is 69842-092. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Ibuprofen And Pseudoephedrine Hcl drug includes Ibuprofen - 200 mg/1 Pseudoephedrine Hydrochloride - 30 mg/1 . The currest status of Ibuprofen And Pseudoephedrine Hcl drug is Active.

Drug Information:

Drug NDC:	69842-092
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:	Ibuprofen And Pseudoephedrine Hcl
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:	Ibuprofen And Pseudoephedrine Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Cvs Pharmacy, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule, Liquid Filled
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:	IBUPROFEN - 200 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE - 30 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:	ANDA
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 Dec, 2017
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:	ANDA209235
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, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1299018
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 M0001335 N0000175722
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	WK2XYI10QM 6V9V2RYJ8N
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]
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 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:	Adrenergic alpha-Agonists [MoA] Anti-Inflammatory Agents Non-Steroidal [CS] Cyclooxygenase Inhibitors [MoA] Nonsteroidal Anti-inflammatory Drug [EPC] alpha-Adrenergic Agonist [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
69842-092-13	4 BLISTER PACK in 1 CARTON (69842-092-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	01 Dec, 2017	N/A	No
69842-092-67	2 BLISTER PACK in 1 CARTON (69842-092-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	01 Dec, 2017	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:

Purposes pain reliever/fever reducer nasal decongestant

Product Elements:

Ibuprofen and pseudoephedrine hcl ibuprofen and pseudoephedrine hcl ibuprofen ibuprofen pseudoephedrine hydrochloride pseudoephedrine ferrosoferric oxide d&c yellow no. 10 gelatin, unspecified hypromellose 2910 (6 mpa.s) fd&c red no. 40 polyethylene glycol 600 potassium hydroxide propylene glycol sorbitol light orange to light yellow with a slight orange hue ibp200

Indications and Usage:

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Warnings:

Warnings allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters if an allergic reaction occurs, stop use and seek medical help right away. 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 heart attack and stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed.

Do Not Use:

When Using:

When using this product take with food or milk if stomach upset occurs

Dosage and Administration:

Directions ? do not take more than directed ? the smallest effective dose should be used ? adults and children 12 years of age and over: ? take 1 capsule every 4 to 6 hours while symptoms persist. if symptoms do not respond to 1 capsule, 2 capsules may be used. ? do not use more than 6 capsules in any 24-hour period unless directed by a doctor ? children under 12 years of age: do not use other information each capsule contains: potassium 20 mg store at 20° to 25°c (68° to 77°f). avoid excessive heat above 40°c (104°f). read all warnings and directions before use. keep carton.

Stop Use:

Stop use and ask a doctor if 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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling fever gets worse or lasts more than 3 days nasal congestion lasts for more than 7 days symptoms continue or get worse redness or swelling is present in the painful area you get nervous, dizzy, or sleepless any new symptoms appear

Package Label Principal Display Panel:

Package label-principal display panel - 200 mg/30 mg (20 liquid-filled capsules) ?cvs health compare to the active ingredients in advil ® cold &sinus** non-drowsy ndc 69842-092-67 cold & sinus relief ibuprofen, usp 200 mg - pain reliever, fever reducer (nsaid) pseudoephedrine hci, usp 30 mg - nasal decongestant ibuprofen & pseudoephedrine hci capsules relieves: sinus pressure nasal congestion & fever 20 liquid-filled capsules (2 x 10 capsules per blister card) actual size package label-principal display panel - 200 mg/30 mg (32 liquid-filled capsules)

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.