ibu profen cold and sinus description, usages, side effects, indications, overdosage, supplying and lots more!

ibu profen cold and sinus

Rite Aid Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Rite Aid Corporation Ibu-Profen Cold & Sinus Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Ibuprofen, USP 200 mg (NSAID)*

Pseudoephedrine HCl, USP 30 mg

*nonsteroidal anti-inflammatory drug

Purpose

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, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Advil® Cold & Sinus

SEE NEW WARNINGS INFORMATION

Relieves sinus pressure, nasal congestion & fever

Non-drowsy

IBU-PROFEN Cold & Sinus

Ibuprofen 200 mg

Pseudoephedrine HCl 30 mg Tablets, USP

Pain Reliever/Fever Reducer (NSAID)*

Nasal Decongestant

*Nonsteroidal anti-inflammatory drug

**OVAL-SHAPED TABLETS

Principal Display Panel
Ibu-Profen Cold & Sinus Carton Image 1 Ibu-Profen Cold & Sinus Carton Image 2

ibu profen cold and sinus

Ibuprofen, Pseudoephedrine Hydrochloride TABLET, SUGAR COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-0083
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 200 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
CALCIUM CARBONATE
carnauba wax
SUCROSE
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
GELATIN
GUAR GUM
hydroxypropyl cellulose
KAOLIN
POLYETHYLENE GLYCOLS
POWDERED CELLULOSE
povidone
SILICON DIOXIDE
SODIUM BENZOATE
talc
titanium dioxide
white wax

Product Characteristics

Color Size Imprint Code Shape
BROWN 15 mm 083 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 NDC:11822-0083-6 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074567 2001-10-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.