NDC 49348-097 Ibuprofen And Pseudoephedrine Hydrochloride

NDC Product Code 49348-097

NDC CODE: 49348-097

Proprietary Name: Ibuprofen And Pseudoephedrine Hydrochloride 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.

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.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: OVAL (C48345)
Size(s):
14 MM
Imprint(s):
423
Score: 1

NDC Code Structure

  • 49348 - Sunmark
    • 49348-097 - Ibuprofen And Pseudoephedrine Hydrochloride

NDC 49348-097-47

Package Description: 20 TABLET, SUGAR COATED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ibuprofen And Pseudoephedrine Hydrochloride with NDC 49348-097 is a product labeled by Sunmark. The generic name of Ibuprofen And Pseudoephedrine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Sunmark

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ACACIA (UNII: 5C5403N26O)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GUAR GUM (UNII: E89I1637KE)
  • TRISTEARIN (UNII: P6OCJ2551R)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • KAOLIN (UNII: 24H4NWX5CO)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WHITE WAX (UNII: 7G1J5DA97F)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sunmark
Labeler Code: 49348
Start Marketing Date: 10-13-2001 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Information for Patients

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 Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients (In Each Caplet)

Ibuprofen, USP 200 mg (NSAID)*Pseudoephedrine HCl, USP 30 mg*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/Fever reducerNasal decongestant

Uses

  • Temporarily relieves these symptoms associated with the common cold or flu:feversinus pressurenasal congestionheadacheminor body aches and pains

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]have 3 or more alcoholic drinks every day while using this producttake 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 reducerif 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 ageright before or after heart surgery

Ask A Doctor Before Use If

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor’s care for any serious conditiontaking any other drugtaking any other product that contains pseudoephedrine or any other nasal decongestanttaking 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 occursthe 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 fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get bettersymptoms continue or get worseany new symptoms appearyou get nervous, dizzy, or sleeplessfever gets worse or lasts more than 3 daysnasal congestion lasts for more than 7 daysredness 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 directedthe smallest effective dose should be usedadults 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 doctorchildren 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.TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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

* Please review the disclaimer below.