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topcare Ibuprofen Cold and Sinus

Dosage form: tablet, sugar coated
Ingredients: IBUPROFEN 200mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Topco Associates LLC
NDC Code: 36800-083

Topco Associates LLC. Ibuprofen Cold & Sinus Drug Facts

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:

  • 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 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 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, 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?

1-888-423-0139

Principal Display Panel

See New Warnings Information

Non-Drowsy

Ibuprofen Cold & Sinus

Ibuprofen 200 mg > Pain Reliever/Fever Reducer (NSAID)*

Pseudoephedrine HCl 30 mg > Nasal Decongestant

Tablets, USP

Relieves Sinus Pressure

Nasal Congestion and Fever

Actual Size

Compare to Advil® Cold & Sinus active ingredients

†Oval-Shaped Tablets

*nonsteroidal anti-inflammatory drug

Ibuprofen Cold & Sinus Carton Image 1

Ibuprofen Cold & Sinus Carton Image 2

TOPCARE IBUPROFEN COLD AND SINUS 
ibuprofen, pseudoephedrine hydrochloride tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-083
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
SUCROSE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GUAR GUM 
HYDROXYPROPYL CELLULOSE 
KAOLIN 
POWDERED CELLULOSE 
POVIDONE 
SILICON DIOXIDE 
SODIUM BENZOATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
WHITE WAX 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBROWNScoreno score
ShapeOVALSize15mm
FlavorImprint Code083
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-083-602 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET, SUGAR COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07456710/09/2001
Labeler - Topco Associates LLC (006935977)

Revised: 05/2010
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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