Ibuprofen and Pseudoephedrine Hydrochloride (ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg) Dailymed
Generic: ibuprofen and pseudoephedrine hydrochloride is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Asthma Bursitis Dysmenorrhea Fever Gout Inflammation Menorrhagia Osteoarthritis Pain Pain, Postoperative Pregnancy Trimester, Third Pregnancy, Abdominal Premenstrual Syndrome Rhinitis Spondylitis, Ankylosing Bronchial Hyperreactivity Common Cold Rhinitis, Allergic, Perennial Sinusitis
IMPRINT: 423
SHAPE: oval
COLOR: brown
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Drug Facts
Otc - Active Ingredient Section
OTC - PURPOSE SECTION
Active ingredients (in each caplet) Purposes
Ibuprofen, USP 200 mg (NSAID)nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Pseudoephedrine HCl, USP 30 mg
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• bulers
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 directedHeart attack and stroke warning
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
• in children under 12 years of age• 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.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, have trouble urinating due to an enlarged prostate gland, or had a stroke• you are taking a diureticAsk a doctor or pharmacist before use if you are
• under a doctor's care for any serious condition• 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• taking any other drugWhen using this product
• take with food or milk if stomach upset occursStop 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• you have symptoms of heart problems or stroke:
• chest pain• trouble breathing• weakness in one part or side of body• slurred speech• leg swelling• fever gets worse or lasts more than 3 days• nasal congestion lasts for more than 7 days• symptoms continue or get worse• redness or swelling is present in the painful area• you get nervous, dizzy, or sleepless• any new symptoms appearOTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
Principal Display Panel - 40 Caplet Blister Pack Carton
†Compare to Advil ® Cold & Sinus active ingredients
NDC 37808-423-40
H-E-B ®
Cold & Sinus Relief
Ibuprofen, USP 200 mg / Pain Reliver/Fever Reducer (NSAID)* Pseudoephedrine HCl, USP 30 mg / Nasal Decongestant
Cold & Sinus *nonsteroidal anti-inflammatory drug
Non-Drowsy
Relief of:
• Fever • Sinus Pressure• Nasal Congestion
40 COATED CAPLETS** (**oval-shaped tablets)
actual size
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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