NDC 51660-493 Ibuprofen And Pseudoephedrine Hydrochloride
Tablet, Sugar Coated Oral

Product Information

What is NDC 51660-493?

The NDC code 51660-493 is assigned by the FDA to the product Ibuprofen And Pseudoephedrine Hydrochloride which is a human over the counter drug product labeled by Ohm Laboratories Inc.. The product's dosage form is tablet, sugar coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 51660-493-41 40 tablet, sugar coated in 1 blister pack . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code51660-493
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Ibuprofen And Pseudoephedrine Hydrochloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Ibuprofen And Pseudoephedrine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormTablet, Sugar Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Ohm Laboratories Inc.
Labeler Code51660
FDA Application Number What is the FDA Application Number?
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.
ANDA074567
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-13-2001
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Ibuprofen And Pseudoephedrine Hydrochloride?


Product Characteristics

Color(s)BROWN (C48332)
ShapeOVAL (C48345)
Size(s)14 MM
Imprint(s)423
Score1

Product Packages

NDC Code 51660-493-41

Package Description: 40 TABLET, SUGAR COATED in 1 BLISTER PACK

Product Details

What are Ibuprofen And Pseudoephedrine Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • IBUPROFEN 200 mg/1 - A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS.
  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1 - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

Ibuprofen And Pseudoephedrine Hydrochloride Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet
  • RxCUI: 1299021 - ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet

Ibuprofen And Pseudoephedrine Hydrochloride Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Ibuprofen And Pseudoephedrine Hydrochloride Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients (In Each Caplet)



Ibuprofen, USP 200 mg (NSAID)*

Pseudoephedrine HCl, USP 30 mg

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever/Fever reducer

Nasal decongestant


Uses



Temporarily relieves these symptoms associated with the common cold or flu:

  • •fever
  • •sinus pressure
  • •nasal congestion
  • •headache
  • •minor body aches and pains

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

Do Not Use



  • •if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • •in children under 12 years of age
  • •right before or after heart surgery

Ask A Doctor Before Use If



  • •stomach bleeding warning applies to you
  • •you have problems or serious side effects from taking pain relievers or fever reducers
  • •you have a history of stomach problems, such as heartburn
  • •you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
  • •you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are



  • •under a doctor’s care for any serious condition
  • •taking any other drug
  • •taking any other product that contains pseudoephedrine or any other nasal decongestant
  • •taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

When Using This Product



  • •take with food or milk if stomach upset occurs
  • •the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
    • •symptoms continue or get worse
    • •any new symptoms appear
    • •you get nervous, dizzy, or sleepless
    • •fever gets worse or lasts more than 3 days
    • •nasal congestion lasts for more than 7 days
    • •redness or swelling is present in the painful area

If Pregnant Or Breast-Feeding



Ask a health professional before use. It is especially important not to use ibuprofen 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
    • •do not use more than 6 caplets in any 24-hour period unless directed by a doctor
    • •children under 12 years of age: do not use

Other Information



  • •store at 20 - 25° C (68 - 77° F). Avoid excessive heat above 40° C (104° F).
  • •read all warnings and directions before use. Keep carton.

Inactive Ingredients



Acacia, calcium carbonate, carnauba wax, confectioner’s sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax


Questions?



Call 1-800-406-7984


Generic Section



TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

5091430 1111


Principal Display Panel



Compare to the active ingredients of Advil® Cold & Sinus

NDC 51660-493-41

ohm®

Non-Drowsy

Cold & Sinus Relief

Ibuprofen and Pseudoephedrine HCl Tablets, USP

IBUPROFEN, USP 200 PAIN RELIEVER/FEVER REDUCER(NSAID)*

PSEUDOEPHEDRINE HCL, USP 30 mg NASAL DECONGESTANT

Relieves Sinus Pressure,

Nasal Congestion and Fever

40 Coated Caplets**

(**oval-shaped tablets)


* Please review the disclaimer below.