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Sunmark Ibuprofen Cold and Sinus

Generic Name: ibuprofen, pseudoephedrine hydrochloride
Dosage Form: tablet

McKesson Ibuprofen Cold and Sinus Drug Facts

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

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*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with the common cold, or flu:

  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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
  • right before or after heart surgery
  • 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

Ask a doctor before use if you have

  • problems or serious side effects from taking pain relievers or fever reducers
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • ulcers
  • bleeding problems
  • high blood pressure
  • heart or kidney disease
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • taken a diuretic
  • reached age 60 or older
  • asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • under a doctor’s care for any serious condition
  • taking any other product that contains pseudoephedrine, or any other nasal decongestant
  • taking aspirin to prevent heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 7 days, unless directed by a doctor (see Warnings)
  • 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, FD&C red no. 40, FD&C yellow no. 6, 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 Advil® Cold & Sinus active ingredients

Ibuprofen Cold & Sinus

Ibuprofen (NSAID)* 200 mg/Pseudoephedrine hydrochloride 30 mg tablets

Pain Reliever, Fever Reducer, Nasal Decongestant

*nonsteroidal anti-inflammatory drug

Relieves Sinus Pressure, Nasal Congestion and Fever

Non-Drowsy

See New Warning & Dosing Directions

**Oval-Shaped Tablets

Ibuprofen Cold and Sinus Carton

Sunmark Ibuprofen Cold and Sinus 
ibuprofen, pseudoephedrine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-431
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 15mm
Flavor Imprint Code 083
Contains         
Packaging
# Item Code Package Description
1 NDC:49348-431-47 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074567 08/28/2003
Labeler - McKesson (177667227)
Revised: 06/2009
 
McKesson



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